MAUDE Adverse Event Report: ABBOTT MEDICAL TEMPORARY PACEMAKER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number 401763

Device Problems Failure to Capture (1081); Perivalvular Leak (1457)

Patient Problem Arrhythmia (1721)

Event Date 02/28/2023

Event Type  Injury  

Event Description

An 81 y/o with pmh(past medical history) of cad(coronary artery disease), nstemi(non-st-elevation myocardial infarction), htn(hypertension), hld(hypersensitivity lung disease), gi(gastro-intestinal) bleed, and pe(pulmonary embolism) presented on (b)(6) 2023 for a tavr(transcatheter aortic valve replacement) in the cardiac cath lab.During the procedure when the valve was deployed, there was a pvc(premature ventricular contraction) during the valve deployment, caused by the temporary pacing catheter failing to cause capture.This caused the valve to deploy approximately 2-3 mm distal to the intended site.Tte(transthoracic echocardiogram) and cineangiography showed substantial perivalvular leak.The deployment catheter was removed.It was felt that failure of the temporary pacing catheter to maintain capture led to the complication/inappropriate placement of valve.

• Brand Name: TEMPORARY PACEMAKER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 16489054
• MDR Text Key: 310865985
• Report Number: MW5115460
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401763
• Device Lot Number: 8594836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White