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

Model Number	9-AVP2-016
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2021 a 16mm amplatzer vascular plug ii was chosen for a aortic paravalvular aneurysm procedure.During placement the physician verified the device placement and the device was released.Upon release, the device embolized into the right atrium and became trapped in the ligaments of the tricuspid valve.Attempts were made to retrieve the device and the attempts were unsuccessful.The patient was taken to or for surgical removal.The surgery was confirmed a success.No consequences to the patient.
Additional Manufacturer Narrative
An event of embolization following off-label implant to close an aortic paravalvular aneurysm was reported.A more comprehensive 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.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11529546
• Report Number: 2135147-2021-00105
• Device Sequence Number: 5257816
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: 00811806010410
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 9-AVP2-016
• Device Catalogue Number: 9-AVP2-016
• Device Lot Number: 6459771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1