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

Model Number	VSD MUSCULAR OCCLUDER
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 16mm amplatzer muscular vsd occluder was chosen for implant.During deployment, the device had a cobra deformation of the right ventricular disc.It was reported there was no interaction of the free wall of the ventricle.A decision was made to replace the device with a second 16mm amplatzer muscular vsd occluder.There was no report of any adverse patient consequences and the patient status was reported as stable.
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 device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Information from field indicated that there was no angulation or kink in the delivery system was noted, it was unknown if there was interaction with cardiac structures during deployment, and an 9f delivery sheath was used.Based on the information reviewed and returned device analysis, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2023, a 16mm amplatzer muscular vsd occluder was chosen for implant.During deployment, the device had a cobra deformation of the right ventricular disc.It was reported there was no interaction of the free wall of the ventricle.The deformed device was never released from the delivery cable while inside the patient and there was no report of any angulation/kink noticed in the delivery system.A decision was made to replace the device with a second 16mm amplatzer muscular vsd occluder.The replacement device was implanted in the patient with no adverse patient consequences.There was no report of any adverse patient consequences and the patient status was reported as stable.It was reported there was a clinically significant delay in the procedure due to this event but it did not lead to hemodynamic compromise of the patient.

• 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: 16667822
• Report Number: 2135147-2023-01451
• Device Sequence Number: 6071753
• Product Code: MLV
• UDI-Device Identifier: 00811806011844
• UDI-Public: 00811806011844
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: VSD MUSCULAR OCCLUDER
• Device Catalogue Number: 9-VSD-MUSC-016
• Device Lot Number: 6702649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2018
• 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
• Patient Age: 63 YR
• Patient Sex: Female