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

Catalog Number	9-VSD-MUSC-016
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	03/26/2024
Type of Reportable Event	Malfunction
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 16mm amplatzer muscular vsd occluder was chosen for implant using a 9f non- abbott delivery sheath.During procedure, the physician noted that the device had a cobra deformation.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.The device was retrieved back.The procedure was terminated.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the condition of the device as returned precluded functional testing.The device was returned to the site and analyzed by s&t.The s&t team discovered a braid wire fracture, a bent braid wire, and braid wire damage.The necking adjacent to the fracture indicates that the occluder experienced an overload condition.It was noted that a significant force would have been required to produce the deformation and ductile overload in niti braided wire.The manufacturing records and s&t report has been reviewed.There were no scrapped parts during the inspection process.There are also specific inspection steps that focus on the cobra deformation and reviewing the device under a microscope to inspect for wire breakage/ damage.The results are inconclusive, but there is evidence that the inspections steps that should catch the issue were completed and there is no identifiable gaps in the manufacturing process.

• 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: 19164006
• Report Number: 2135147-2024-01809
• Device Sequence Number: 7085524
• Product Code: MLV
• UDI-Device Identifier: 00811806011844
• UDI-Public: (01)00811806011844(17)240331(10)6968610
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 03/31/2024
• Device Catalogue Number: 9-VSD-MUSC-016
• Device Lot Number: 6968610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 9F COOK MULLIN SHEATH.
• Patient Sex: Unknown