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

Catalog Number	9-VSDMPIHDE-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Shock (2072)
Date of Event	12/31/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2023, a 18mm amplatzer pi musc vsd for emergent implant in a patient who had cardiogenic shock with ventricular septal defect post myocardial infarction on (b)(6) 2023.The implant procedure was successful and device was implanted in stable position.Patient was discharged to a skilled nursing facility on (b)(6) 2024.On (b)(6) 2023, the patient was re-admitted in cardiogenic shock and bradycardia.The patient expired on the same day.The death is not thought to be device related.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.
Additional Manufacturer Narrative
An event of cardiogenic shock, bradycardia and patient death few days post implant was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Patient comorbidity includes cardiogenic shock with ventricular septal defect post myocardial infarction which could have contributed for reported cardiogenic shock and bradycardia.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Additionally it was indicated that the death is not thought to be device related.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.From medical review: "patients with a post-infarct vsd have a high 30-day mortality rate consistent with this case.The exact cause of death remains unknown, but most likely related to the underlying medical condition following an acute myocardial infarction.Patient related.Possibly procedure related.Unknown if device related.".

• Brand Name: AMPLATZER POST-INFARCT VSD OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18711658
• Report Number: 2135147-2024-00674
• Device Sequence Number: 8192212
• Product Code: MLV
• UDI-Device Identifier: 05415067028112
• UDI-Public: (01)05415067028112(17)270930(10)8712654
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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 Catalogue Number: 9-VSDMPIHDE-018
• Device Lot Number: 8712654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female