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

Model Number	9-AVP2-012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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
It was reported that a 12mm amplatzer vascular plug ii was selected for use in the left subclavian for a thoracic endovascular aortic repair (tevar) case on (b)(6) 2021.During the procedure, the physician went through the right groin and into the subclavian.As the physician was repositioning the plug it some how came off the delivery wire.It was left hanging partially in the subclavian and partially in the aorta.The physician then had to stick the left brachial and snare the plug and put it in the correct place.The patient did not experience any serious injuries and the plug remains implanted.The patient was hemodynamically stable throughout the entire procedure, but there was a 30 minute clinically significant delay to the procedure.The patient is currently stable and was discharged from the hospital on (b)(6) 2021.
Additional Manufacturer Narrative
An event of amplatzer vascular plug ii device detachment from delivery wire 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: 11961822
• Report Number: 2135147-2021-00230
• Device Sequence Number: 16488142
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 7601616
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 32