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

Model Number	VSD MUSCULAR OCCLUDER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/29/2022
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
This event is being conservatively reported for death as the cause of death post procedure is unknown.It was reported that an 8mm amplatzer muscular ventricular septal defect (vsd) occluder was chosen for procedure on (b)(6) 2022 for closure of a ventricular pseudoaneurysm.During the procedure the device was initially deployed for placement however it was determined to be too small.The device was removed prior to being released from the cable.During preparation of the replacement device, a 10mm amplatzer muscular vsd occluder, the patient became hypotensive and hemodynamically unstable requiring chest compressions.Return of spontaneous circulation (rosc) was achieved after 31 minutes of cardiopulmonary resuscitation (cpr).During chest compressions, the 10mm amplatzer vsd occluder was successfully implanted.An intra-aortic balloon pump (iabp) and a left ventricular assist device (lvad) (impella) were placed.The patient was given epinephrine and pressor.The patient's condition did eventually stabilize, their blood pressure and cardiac function had improved with the interventions.The procedure was completed with the patient in stable condition.Later that same day, post procedure, the patient had passed away on (b)(6) 2022.The cause of death is unknown.No additional information has been provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of patient death after a procedure to implant an amplatzer vsd device due to unknown causes and miss-sizing of the device was reported.Additional information on the cause of the patient death as well as imaging and procedure notes, however no additional information was received.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 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.

• 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: 14191650
• Report Number: 2135147-2022-00210
• Device Sequence Number: 14591669
• Product Code: MLV
• UDI-Device Identifier: 00811806011806
• UDI-Public: 00811806011806
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2022

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 Model Number: VSD MUSCULAR OCCLUDER
• Device Catalogue Number: 9-VSD-MUSC-008
• Device Lot Number: 8255216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 07/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male