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

Model Number	9-AVP2-010
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of device 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.
Event or Problem Description
Related manufacturer report number: 2135147-2021-00565.On an unknown date, two 10mm amplatzer vascular plug ii were successfully implanted in a patient.On an unknown date, both plugs were found to have migrated down into the abdominal aorta.The patient was brought to surgery where the plugs were successfully snared and replaced with two larger plugs to resolve the event.The physician thought the event was due to the plugs used being too small in diameter or that the patients anatomy changed, there was no allegation against the abbott devices.The patient is stable.No additional information as 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
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13015213
• Report Number: 2135147-2021-00564
• Device Sequence Number: 4625836
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: 00811806010380
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 06/30/2026
• Device Model Number: 9-AVP2-010
• Device Catalogue Number: 9-AVP2-010
• Device Lot Number: 8044596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 80 KG