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

Model Number	9-AVP2-012
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event of deformity of device upon deployment 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.
Event or Problem Description
It was reported that on (b)(6) 2021, a 12 mm amplatzer vascular plug ii device was chosen for a thoracic aortic aneurysm (taa) case.During procedure, the device was attempted to be deployed in the right subclavian artery, but the device did not take the proper shape.The device was removed from the patient, and the case was abandoned.There was no clinically significant delay in procedure and no adverse patient effects.The patient remained hemodynamically stable throughout the procedure.The patient status was reported as stable.No additional information was provided.

• 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: 12481267
• Report Number: 2135147-2021-00364
• Device Sequence Number: 3794547
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 09/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 7839277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1