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

Catalog Number	9-VSDMPIHDE-024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hypoxia (1918); Cardiac Tamponade (2226); Pericardial Effusion (3271); Insufficient Information (4580)
Date of Event	06/17/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 24mm amplatzer post-infarct muscular vsd occluder was chosen for implant to close a post-infarct ventricular septal defect with an inferior wall pseudoaneurysm.The occluder was successfully implanted to close the defect.There were no complications during the procedure.Post procedure, the patient experienced cardiac tamponade, hypoxia, and cardiac arrest.The patient died on (b)(6) 2024.
Additional Manufacturer Narrative
H6 - adverse event problem: health effect - clinical code: removed code 4580 insufficient information.Added code 3271 pericardial effusion, 2226 cardiac tamponade, 1918 hypoxia, 1762 cardiac arrest.An event of pericardial effusion with cardiac tamponade, hypoxia, cardiac arrest and patient death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.It was noted that device did not caused the pericardial effusion.Also indicated that the cause of death was believed to be related to the patient's co-morbidities.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 death could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From medical review: the patient died due to the acute pericardial effusion which most likely was related to the implant procedure considering the event occurred post-procedure.There is no mention how the left ventricular pseudo-aneurysm was managed, but it might be possible that the left ventricular pseudo-aneurysm ruptured post implant due to instrumentation at the time of the procedure and resulted in the pericardial effusion and cardiac arrest.
Event or Problem Description
It was reported that on (b)(6) 2024, a 24mm amplatzer post-infarct muscular vsd occluder was chosen for implant to close a post-infarct ventricular septal defect with an inferior wall pseudoaneurysm.The occluder was successfully implanted to close the defect using a non-abbott delivery sheath.There was no difficulty implanting the device, and one delivery sheath exchange was performed.There were no complications during the procedure.Post procedure, the patient experienced pericardial effusion with cardiac tamponade, hypoxia, and cardiac arrest.The patient died on (b)(6) 2024 due to cardiac arrest.The physician did not believe that the device caused the pericardial effusion.The cause of death was believed to be related to the patient's co-morbidities.

• 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: 19732802
• Report Number: 2135147-2024-03382
• Device Sequence Number: 12528279
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: (01)05415067028143(17)281130(10)10120834
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/25/2024

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-024
• Device Lot Number: 10120834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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: 87 YR
• Patient Sex: Male