MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problem Biocompatibility (2886)

Patient Problems Atrial Fibrillation (1729); Renal Failure (2041); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

The article ¿elaborate evaluation of serial changes in electrocardiograms of atrial septal defects after transcatheter closure for a better understanding of the recovery process" was reviewed.This article was a retrospective study to examine the serial changes apparent on ecg and other clinical parameters before and after transcatheter closure of asd.Septal occluders associated with this study include amplatzer septal occluder (abbott) and occlutech figulla flex ii (occlutech inc).There was no allegation against an abbott device.The primary author is min-jeong kang, md, of department of health sciences, graduate school of medical sciences, kyushu university, fukuoka, japan.The corresponding author is akiko chishaki, with corresponding email: chishaki@college.Fdcnet.Ac.Jp.

Manufacturer Narrative

As reported in a research article, of 105 patients whom had a asd closed, 5 had heart block, 1 had renal failure with dialysis and 1 patient had persistent atrial fibrillation which required a pacemaker.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 SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10211605
• MDR Text Key: 201019255
• Report Number: 2135147-2020-00253
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention