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

Model Number	9-AVP2-022
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 22mm amplatzer vascular plug ii was selected for implant.During the procedure, the device kept migrating to the aorta.The prosthesis was removed and an amplatzer vascular plug i was successfully implanted instead.When the patient became conscious, it was noted that she had suffered a right side cerebrovascular accident.The physician stated that the event may have been caused by the patient's history of heparin induced thrombocytopenia, activated clotting time levels and the maneuvering of the device.Medication was administered to the patient, and is reported to be recovering.
Additional Manufacturer Narrative
An event of an amplatzer vascular plug ii migration 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): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10215365
• Report Number: 2135147-2020-00293
• Device Sequence Number: 2273248
• Product Code: KRD
• UDI-Device Identifier: 00811806010441
• UDI-Public: 00811806010441
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K0701699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 9-AVP2-022
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 7288347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention