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

Model Number	9-VSDMPIHDE-024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); Pericardial Effusion (3271)
Date of Event	10/16/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
While attempting a post mi vsd procedure on an (b)(6) year old woman with a recent traumatic ventricular septal rupture due to a myocardial infarction, a wire and an 11f cook sheath were placed across the defect from the venous side into the lv.Upon prepping the amplatzer 24mm pmivsd device it was noticed on tee that the patient was developing a pericardial effusion.It was decided to first deploy device then deal with the effusion.The device was delivered and deployed.The physician then proceeded to prep for the pericardial drain.The pericardial space was drained and the patient was being monitored.Despite the efforts of the team the patient died in the room.
Additional Manufacturer Narrative
An event of pericardial effusion and patient death was reported.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10832605
• Report Number: 2135147-2020-00473
• Device Sequence Number: 19895249
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: H070005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 9-VSDMPIHDE-024
• Device Catalogue Number: 9-VSDMPIHDE-024
• Device Lot Number: 7287636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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: Death
• Patient Age: 88 YR