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

Model Number	POST INFARCT MUSCULAR VSD OCCLUDER
Medical Device Problem Codes	Off-Label Use (1494); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hemolytic Anemia (2279)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_894 - pivsd.It was reported that on (b)(6) 2022, the patient presented to the emergency department with hypotension and lactic acidosis likely due to cardiogenic shock, and patient was admitted.On (b)(6) 2022, a 22mm amplatzer post-infarct muscular vsd occluder was implanted to close a mitral paravalvular leak, which was off-label use of the device.Post procedure, the patient had hematuria with lab abnormalities consistent with hemolysis from implanted devices.On (b)(6) 2022, the patient had surgical re-operation to remove the device and to repair the mitral paravalvular leak.On (b)(6) 2022, the patient was discharged to a long-term acute care hospital.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of the hemolysis was reported.Field indicated that hematuria and lab abnormalities from implanted devices were consistent may have contributed to the reported event.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.Per instructions for use, the amplatzer mu vsd pi is a percutaneous, transcatheter occlusion device, intended for the non-surgical closure of a muscular ventricle septal defect after myocardial infarction.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: the physician decided the device due to massive mitral pvl unable to close with two avp ii 20mm devices.The physician used the largest vsd occluder in conjunction with a 20mm avp ii device.This combination of devices was the only combination in this complex paravalvular leak to show significant reduction in pvl for this patient who was in acute heart failure.Post procedure, the patient had hematuria with lab abnormalities consistent with hemolysis from implanted devices.The patient receive blood transfusions to address the hemolysis.On (b)(6) 2022, the patient had surgical re-operation to remove the device and to repair the mitral paravalvular leak.On (b)(6) 2022, the patient was discharged to a long-term acute care hospital.

• 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: 16389926
• Report Number: 2135147-2023-00549
• Device Sequence Number: 12033816
• Product Code: MLV
• UDI-Device Identifier: 05415067028136
• UDI-Public: 05415067028136
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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: 10/31/2024
• Device Model Number: POST INFARCT MUSCULAR VSD OCCLUDER
• Device Catalogue Number: 9-VSDMPIHDE-022
• Device Lot Number: 7250560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 50 KG