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

Model Number 9-VSDMPIHDE-024

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

Patient Problems Death (1802); Myocardial Infarction (1969); Pericardial Effusion (3271)

Event Date 10/16/2020

Event Type  Death  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event 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.

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
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10832605
• MDR Text Key: 216009465
• Report Number: 2135147-2020-00473
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (y/n): N
• PMA/PMN Number: H070005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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 Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR