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

Device Problems Migration or Expulsion of Device (1395); Biocompatibility (2886)

Patient Problems Headache (1880); 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 "feasibility of transcatheter closure of secundum atrial septal defect in low weight infants under 2-year-old from a three-year retrospective cohort study" was reviewed.This article was a retrospective study to evaluate the feasibility of interventional treatment of atrial septal defects (asd) in low weight infants under 2-year-old.From january 2011 to december 2016, 793 secundum asd patients were divided into two groups: 665 were above 2-year-old and 128 were under 2-year-old.Transcatheter occluders from different manufacturers are associated with the study including beijing huayi shengjie asd occluder, lifetech scientific asd occluder, boat fit asd occluder, and abbott amplatzer septal occluder.There was no allegation of malfunction against the abbott device.The primary author is chunhui cao, md, department of cardiology, shenzhen hospital, southern medical university, guangdong, china.The corresponding author is zhiwei zhang, with corresponding email: drzhangzw@sohu.Com.

Manufacturer Narrative

As reported in a research article, patients implanted with an amplatzer septal occluder included embolization of the device, headache, residual shunt, and arrythmia.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: 10284991
• MDR Text Key: 200813794
• Report Number: 2135147-2020-00319
• 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: 08/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention