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

Model Number	9-ASD-034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/14/2019
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9444333
• Report Number: 2135147-2019-00421
• Device Sequence Number: 3231220
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: 00811806010243
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention