MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problem Off-Label Use (1494)

Patient Problems Hemolysis (1886); Cardiac Tamponade (2226); Cardiac Perforation (2513); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturing reference number : 2135147-2021-00191, 2135147-2021-00193.The article, "transcatheter closure of paravalvular leak: multicenter experience and follow-up", was reviewed.This research article is a retrospective multi-center experience to assess clinical outcomes of consecutive patients with paravalvular leak(pvl) treated with transcatheter techniques.Occlutech paravalvular leak device(occlutech), ampaltzer vascular plug and amplatzer duct occluder(abbott) were associated with the study.There is no allegation of malfunction of the abbott devices.The article concluded that transcatheter closure of pvl can be performed with high technical and clinical success rates and limited complications that lead to significant pvl reduction and functional status improvement.The primary and correspondence author of the article is konstantinos kalogeras, md, phd, 3rd department of cardiology, sotiria hospital, medical school, national & kapodistrian university of athens, athanasiou diakou 23, ilioupoli, 16342, greece with the corresponding email: kalogerask@yahoo.Gr.

Manufacturer Narrative

As reported in a research article, perforation, cardiac tamponade, pvl, hemolysis and re-operation occurred following off label implant to mitigate paravalvular leakage.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11829097
• MDR Text Key: 250841213
• Report Number: 2135147-2021-00192
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR