U.S. flag

An official website of the United States government

Format

Send to:

Choose Destination

Unanticipated Adverse Device Effect

MedGen UID:
1749536
•Concept ID:
C5419427
•
Pathologic Function

Definition

Complication occurring in the patient that had not previously been identified or expected for this device. [from NCI]

Term Hierarchy

CClinical test,  RResearch test,  OOMIM,  GGeneReviews,  VClinVar  
  • CROGVUnanticipated Adverse Device Effect

Professional guidelines

PubMed

Metal stent for the ureteral stricture after surgery and/or radiation treatment for malignancy.
Wang W, Gao X, Chen J, Liu Z, Peng L, Wei X
BMC Urol 2021 Oct 16;21(1):146. doi: 10.1186/s12894-021-00912-6. PMID: 34656100Free PMC Article
Evaluation of the Safety and Feasibility of Same-Day Holmium-166 -Radioembolization Simulation and Treatment of Hepatic Metastases.
van Roekel C, Harlianto NI, Braat AJAT, Prince JF, van den Hoven AF, Bruijnen RCG, Lam MGEH, Smits MLJ
J Vasc Interv Radiol 2020 Oct;31(10):1593-1599. Epub 2020 Aug 27 doi: 10.1016/j.jvir.2020.01.032. PMID: 32861571
Perioperative antiplatelet management in patients with coronary artery stenting.
Tandar A, Velagapudi KN, Wilson BD, Boden WE
Hosp Pract (1995) 2012 Apr;40(2):118-30. doi: 10.3810/hp.2012.04.977. PMID: 22615086

Recent clinical studies

Etiology

Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes.
Lee TTM, Collett C, Bergford S, Hartnell S, Scott EM, Lindsay RS, Hunt KF, McCance DR, Barnard-Kelly K, Rankin D, Lawton J, Reynolds RM, Flanagan E, Hammond M, Shepstone L, Wilinska ME, Sibayan J, Kollman C, Beck R, Hovorka R, Murphy HR; AiDAPT Collaborative Group
N Engl J Med 2023 Oct 26;389(17):1566-1578. Epub 2023 Oct 5 doi: 10.1056/NEJMoa2303911. PMID: 37796241
Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia.
Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martínez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators
N Engl J Med 2023 Mar 30;388(13):1171-1180. doi: 10.1056/NEJMoa2212754. PMID: 36988592
The SANTÉ study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy.
Salanova V, Sperling MR, Gross RE, Irwin CP, Vollhaber JA, Giftakis JE, Fisher RS; SANTÉ Study Group
Epilepsia 2021 Jun;62(6):1306-1317. Epub 2021 Apr 8 doi: 10.1111/epi.16895. PMID: 33830503
Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial.
Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Pürerfellner H
JACC Clin Electrophysiol 2019 Jul;5(7):778-786. Epub 2019 May 8 doi: 10.1016/j.jacep.2019.04.009. PMID: 31320006
Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia.
Cook TM, Woodall N, Frerk C; Fourth National Audit Project
Br J Anaesth 2011 May;106(5):617-31. Epub 2011 Mar 29 doi: 10.1093/bja/aer058. PMID: 21447488

Diagnosis

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial.
Kapural L, Patterson DG, Li S, Hatheway J, Hunter C, Rosen S, Fishman M, Gupta M, Sayed D, Christopher A, Burgher A, McJunkin T, Ross EL, Provenzano D, Amirdelfan K
Neuromodulation 2023 Oct;26(7):1400-1411. Epub 2023 Aug 16 doi: 10.1016/j.neurom.2023.05.006. PMID: 37589641
Stuck OCT Catheter: An Unanticipated Complication.
Chhikara S, Datta R, Shrivastava A, Gupta A
J Invasive Cardiol 2022 Feb;34(2):E149-E150. PMID: 35100558
Multicenter, prospective, observational study of a novel technique for preoperative pulmonary nodule localization.
Fan L, Yang H, Yu L, Wang Z, Ye J, Zhao Y, Cai D, Zhao H, Yao F
J Thorac Cardiovasc Surg 2020 Aug;160(2):532-539.e2. Epub 2019 Nov 14 doi: 10.1016/j.jtcvs.2019.10.148. PMID: 31866078
Transcatheter aortic valve implantation: status and challenges.
Fishbein GA, Schoen FJ, Fishbein MC
Cardiovasc Pathol 2014 Mar-Apr;23(2):65-70. Epub 2013 Oct 8 doi: 10.1016/j.carpath.2013.10.001. PMID: 24183003
Acceptability and utility of the mySentry remote glucose monitoring system.
Kaiserman K, Buckingham BA, Prakasam G, Gunville F, Slover RH, Wang Y, Nguyen X, Welsh JB
J Diabetes Sci Technol 2013 Mar 1;7(2):356-61. doi: 10.1177/193229681300700211. PMID: 23566993Free PMC Article

Therapy

Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes.
Lee TTM, Collett C, Bergford S, Hartnell S, Scott EM, Lindsay RS, Hunt KF, McCance DR, Barnard-Kelly K, Rankin D, Lawton J, Reynolds RM, Flanagan E, Hammond M, Shepstone L, Wilinska ME, Sibayan J, Kollman C, Beck R, Hovorka R, Murphy HR; AiDAPT Collaborative Group
N Engl J Med 2023 Oct 26;389(17):1566-1578. Epub 2023 Oct 5 doi: 10.1056/NEJMoa2303911. PMID: 37796241
The SANTÉ study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy.
Salanova V, Sperling MR, Gross RE, Irwin CP, Vollhaber JA, Giftakis JE, Fisher RS; SANTÉ Study Group
Epilepsia 2021 Jun;62(6):1306-1317. Epub 2021 Apr 8 doi: 10.1111/epi.16895. PMID: 33830503
Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial.
Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Pürerfellner H
JACC Clin Electrophysiol 2019 Jul;5(7):778-786. Epub 2019 May 8 doi: 10.1016/j.jacep.2019.04.009. PMID: 31320006
Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia.
Cook TM, Woodall N, Frerk C; Fourth National Audit Project
Br J Anaesth 2011 May;106(5):617-31. Epub 2011 Mar 29 doi: 10.1093/bja/aer058. PMID: 21447488
Fiberoptic techniques.
Koerner IP, Brambrink AM
Best Pract Res Clin Anaesthesiol 2005 Dec;19(4):611-21. doi: 10.1016/j.bpa.2005.07.006. PMID: 16408537

Prognosis

The SANTÉ study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy.
Salanova V, Sperling MR, Gross RE, Irwin CP, Vollhaber JA, Giftakis JE, Fisher RS; SANTÉ Study Group
Epilepsia 2021 Jun;62(6):1306-1317. Epub 2021 Apr 8 doi: 10.1111/epi.16895. PMID: 33830503
Multicenter, prospective, observational study of a novel technique for preoperative pulmonary nodule localization.
Fan L, Yang H, Yu L, Wang Z, Ye J, Zhao Y, Cai D, Zhao H, Yao F
J Thorac Cardiovasc Surg 2020 Aug;160(2):532-539.e2. Epub 2019 Nov 14 doi: 10.1016/j.jtcvs.2019.10.148. PMID: 31866078
Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea.
Fox H, Oldenburg O, Javaheri S, Ponikowski P, Augostini R, Goldberg LR, Stellbrink C, Mckane S, Meyer TE, Abraham WT, Costanzo MR
Sleep 2019 Oct 21;42(11) doi: 10.1093/sleep/zsz158. PMID: 31634407Free PMC Article
Complications and failure of airway management.
Cook TM, MacDougall-Davis SR
Br J Anaesth 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393. PMID: 23242753
Complications of posterior cervical plating.
Heller JG, Silcox DH 3rd, Sutterlin CE 3rd
Spine (Phila Pa 1976) 1995 Nov 15;20(22):2442-8. doi: 10.1097/00007632-199511001-00013. PMID: 8578396

Clinical prediction guides

A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding.
Curlin HL, Cintron LC, Anderson TL
J Minim Invasive Gynecol 2021 Apr;28(4):899-908. Epub 2020 Aug 22 doi: 10.1016/j.jmig.2020.08.013. PMID: 32835865
Oxytocin for preventing postpartum haemorrhage (PPH) in non-facility birth settings.
Pantoja T, Abalos E, Chapman E, Vera C, Serrano VP
Cochrane Database Syst Rev 2016 Apr 14;4(4):CD011491. doi: 10.1002/14651858.CD011491.pub2. PMID: 27078125Free PMC Article
Pacemakers and implantable cardioverter defibrillators--general and anesthetic considerations.
Rapsang AG, Bhattacharyya P
Braz J Anesthesiol 2014 May-Jun;64(3):205-14. Epub 2013 Oct 16 doi: 10.1016/j.bjane.2013.02.005. PMID: 24907883
A contemporary review of mechanical circulatory support.
Patel CB, Cowger JA, Zuckermann A
J Heart Lung Transplant 2014 Jul;33(7):667-74. Epub 2014 Feb 21 doi: 10.1016/j.healun.2014.02.014. PMID: 24721183
Complications and failure of airway management.
Cook TM, MacDougall-Davis SR
Br J Anaesth 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393. PMID: 23242753

Recent systematic reviews

The role of hemoadsorption in cardiac surgery - a systematic review.
Matejic-Spasic M, Lindstedt S, Lebreton G, Dzemali O, Suwalski P, Folliguet T, Geidel S, Klautz RJM, Baufreton C, Livi U, Gunaydin S, Deliargyris EN, Wendt D, Thielmann M
BMC Cardiovasc Disord 2024 May 18;24(1):258. doi: 10.1186/s12872-024-03938-4. PMID: 38762715Free PMC Article
General versus loco-regional anesthesia for endovascular aortic aneurysm repair.
Lee S, You C, Kucey A, Alam F, Papia G, Kucey DS, Forbes T, Choi S, Dueck AD, Kayssi A
Cochrane Database Syst Rev 2023 Apr 13;4(4):CD013182. doi: 10.1002/14651858.CD013182.pub2. PMID: 37052421Free PMC Article
The impact of continuous wireless monitoring on adverse device effects in medical and surgical wards: a review of current evidence.
Aagaard N, Larsen AT, Aasvang EK, Meyhoff CS
J Clin Monit Comput 2023 Feb;37(1):7-17. Epub 2022 Aug 2 doi: 10.1007/s10877-022-00899-x. PMID: 35917046
Oxytocin for preventing postpartum haemorrhage (PPH) in non-facility birth settings.
Pantoja T, Abalos E, Chapman E, Vera C, Serrano VP
Cochrane Database Syst Rev 2016 Apr 14;4(4):CD011491. doi: 10.1002/14651858.CD011491.pub2. PMID: 27078125Free PMC Article
Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape for treatment of urinary stress incontinence.
Cody J, Wyness L, Wallace S, Glazener C, Kilonzo M, Stearns S, McCormack K, Vale L, Grant A
Health Technol Assess 2003;7(21):iii, 1-189. doi: 10.3310/hta7210. PMID: 13678548

Supplemental Content

Table of contents

    Practice guidelines

    • PubMed
      See practice and clinical guidelines in PubMed. The search results may include broader topics and may not capture all published guidelines. See the FAQ for details.
    • Bookshelf
      See practice and clinical guidelines in NCBI Bookshelf. The search results may include broader topics and may not capture all published guidelines. See the FAQ for details.

    Recent activity

    Clear Turn Off Turn On

    Your browsing activity is empty.

    Activity recording is turned off.

    Turn recording back on

    See more...