MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER

Device Problem Off-Label Use (1494)

Patient Problems Hemolysis (1886); Renal Failure (2041)

Event Date 03/02/2021

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: 2135147-2021-00152.The article, "transcatheter closure of mitral paravalvular leak via multiple approaches", was reviewed.This research article is a retrospective multi center experience to review the experiences with transcatheter closure of mitral paravalvular leak(pvl) after surgical valve replacement.Amplatzer septal occluder, amplatzer muscular ventricular septal occluder, amplatzer duct occluder and amplatzer vascular plug ii(avp ii) were associated with the study.There is no allegation of malfunction of the abbott devices.The article concluded that transcatheter mitral pvl closure requires complex catheter techniques.However, this minimally invasive treatment could provide reliable outcomes and shorter hospital stays in selected patients.The primary author of the article is yang liu, department of cardiovascular surgery, xijing hospital, air force medical university, xi¿an, china.The correspondence author of the article is yang liu, department of cardiovascular surgery, xijing hospital, air force medical university, xi¿an, china with the corresponding email: yangjian1212@hotmail.Com.

Manufacturer Narrative

As reported in a research article, hemolysis, acute renal insufficiency, recurrent hemoglobinuria and anemia were noted following off-label closure of paravalvular leaks.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.This research was reported to have been conducted between january 2015 and december 2019.At this time, no amplatzer closure products were indicated for use for the closure of paravalvular leakage.

• Brand Name: AMPLATZER OCCLUDER (UNKNOWN)
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11697984
• MDR Text Key: 246466993
• Report Number: 2135147-2021-00151
• Device Sequence Number: 1
• Product Code: MLV
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR