MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-VSDMPIHDE-024

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Date 11/25/2021

Event Type  Death  

Manufacturer Narrative

An event of "the device slipped into the right ventricle prior to being released from the cable", hypotension, ventricular rupture, 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.

Event Description

It was reported that on (b)(6) 2021, a 24mm amplatzer post-infarct muscular vsd occluder was selected for implant in a patient with a past medical history of severely reduced right and left ventricular function, cardiogenic shock, multi-organ failure, and morbid obesity.During procedure, the left ventricular disk was deployed in the left ventricle, followed by the right ventricular disk in the right ventricle, however, the device slipped into the right ventricle prior to being released from the cable.Shortly after, the patient became hypotensive, resulting in hemodynamic instability and the patient passed away, presumed to be from a ventricular rupture.The user alleged that the patient's passing was due to the procedure and the patient's comorbidities.

• Brand Name: AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13056568
• MDR Text Key: 282603351
• Report Number: 2135147-2021-00539
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H070005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 9-VSDMPIHDE-024
• Device Catalogue Number: 9-VSDMPIHDE-024
• Device Lot Number: 6980608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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): Death
• Patient Age: 83 YR
• Patient Sex: Female