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

Catalog Number	9-VSD-MUSC-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Heart Block (4444)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event for the patient effects of cardiac arrest and heart block was reported.A returned device 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 available information, a cause for the reported cardiac arrest could not be determined.The patient effect of heart block appears to be related to procedural conditions.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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 18mm amplatzer muscular vsd occluder was chosen for implant.During device deployment, the device touched the atrioventricular (av) connection area, causing a complete heart block.The patient had a course of asystole and was provided with a temporary pacemaker.Underlying rhythm returned.The device was implanted.The patient status was reported as stable.

• Brand Name: AMPLATZER MUSCULAR 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: 20667647
• Report Number: 2135147-2024-05709
• Device Sequence Number: 8208315
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: (01)00811806011851(17)271031(10)8742739
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/02/2024

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-VSD-MUSC-018
• Device Lot Number: 8742739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown