MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	9-PLUG-016
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 10 november 2023, a 16mm amplatzer vascular plug was selected for an implant for embolization of subclavian artery as part of complex thoracic endovascular aortic repair (tevar) procedure.Plug was unsheathed to subclavian artery via brachial puncture and 6f sheath.Sizing/positioning confirmed, plug well apposed to vessel.Pusher wire turned counterclockwise many times to detach, (could not recall how many times the pusher was turned) but plug would not detach.After some movement back and forth with the pusher wire, plug detached.On later imaging (6 week follow up scan) it appears the plug has partially pushed through subclavian artery.Patient has been discharged and no further comments from surgeon around the device or concerns for the patient except to report unusual findings on post imaging.
Additional Manufacturer Narrative
An event of difficulty releasing the plug from the cable and the plug migrating was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A returned device assessment, to see if there was a device related issue, could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated the case was challenging.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER VASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 18256695
• Report Number: 2135147-2023-05317
• Device Sequence Number: 20494197
• Product Code: KRD
• UDI-Device Identifier: 00811806011509
• UDI-Public: 00811806011509
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 12/04/2023

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 Catalogue Number: 9-PLUG-016
• Device Lot Number: 8649482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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
• Patient Sex: Unknown