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

Model Number 9-ASD-034

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Death (1802); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 11/14/2019

Event Type  Death  

Manufacturer Narrative

An event of hypotension and cardiac arrest during device deployment, cardiac effusion, and patient death due to an aneurysm rupture was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The patient was undergoing a post-infarct ventricular septal defect closure (vsd).An echocardiogram was performed which revealed a large aneurysm in the ventricle, near the vsd.Initially a 24mm vsd was selected but deemed too small, so a 34mm amplatzer septal occluder was selected.During deployment, the patient became hypotensive and went into cardiac arrest.An echocardiogram revealed a cardiac effusion and resuscitation efforts were undertaken for 45 minutes when the patient was pronounced dead.The aneurysm had ruptured leading to the effusion.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9444333
• MDR Text Key: 170050849
• Report Number: 2135147-2019-00421
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: 00811806010243
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 5070830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention