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

Model Number	9-AVP2-020
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2021, a 20mm amplatzer vascular plug ii was implanted.During radiographic control the physician observed that the plug had migrated to the left pulmonary artery.The physician attempted to retrieve the plug with a cook angiography catheter however, the tip separated and the plug and distal catheter could not retrieved and remained in the patient.On (b)(6) 2021, a thoracotomy and arteriotomy was performed to retrieve the plus and the catheter tip.The device was entrapped in the pulmonary artery which was responsible for a thrombosis of the atrial branches at the inferior left lung.The patient was put on anticoagulant treatment for the next 3 months.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of device embolism was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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: 11561889
• Report Number: 2135147-2021-00104
• Device Sequence Number: 17363788
• Product Code: KRD
• UDI-Device Identifier: 00811806010434
• UDI-Public: 00811806010434
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K0701699
• 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): 05/28/2021

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: 10/31/2025
• Device Model Number: 9-AVP2-020
• Device Catalogue Number: 9-AVP2-020
• Device Lot Number: 7756673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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; Required Intervention