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

Model Number 9-ASD-040

Device Problem Biocompatibility (2886)

Patient Problems Pleural Effusion (2010); Cardiac Tamponade (2226); Pericardial Effusion (3271)

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 "not just another large atrial septal defect: complex anatomy, challenging procedure, and an unusual complication" was reviewed.This article is a case report of a patient with a complex atrial septal defect in whom a 40-mm amplatzer septal occluder was implanted.During deployment of the device, deployment maneuvers led to an immediate pericardial effusion that was closely monitored and uneventfully drained 11 days later after imaging showed signs of tamponade.The occluder was surgically extracted 50 days following implantation due to recurrence of pericardial effusion, chest pain and dyspnea.The defect was surgically repaired, and the patient was reported to be discharged.The primary author is raymond n.Haddad, md, of department of pediatrics, hotel dieu de france university medical center, saint joseph university, beirut, lebanon.The corresponding email is: raymondhaddad@live.Com.

Manufacturer Narrative

As reported in a research article, a patient had a pericardial effusion during the deployment of the device, which reoccurred 50 days after the implant resulting in the device being explanted.The patient also experienced chest pain and dyspnea.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: 10299861
• MDR Text Key: 200814910
• Report Number: 2135147-2020-00322
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-040
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR