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

Model Number	9-AVP2-012
Medical Device Problem Codes	Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 12mm amplatzer vascular plug ii ((b)(4)) was chosen for implant in an emergency left internal iliac artery aneurysm rupture case using a 5f non-abbott delivery system.At the start of the procedure, 10,000 units of heparin were administered intravenously.After the delivery system was delivered to the left aneurysm rupture site, it was attempted to deliver the device, but strong resistance was encountered near the right common iliac artery.The device was not able to be delivered to the aneurysm site and was not deployed inside the patient.It was noted that there was mild tortuosity of the right common iliac artery.It was believed that the lumen was not flat, and a defect was suspected in the device.The device ((b)(4) ) was removed from the patient.It was observed that the device ((b)(4)) had a small amount of a thrombus-like substance was attached.A new 12mm amplatzer vascular plug ii ((b)(4)) was chosen for implant.The device was delivered to the right common iliac artery without resistance and placed without issue.The procedure was concluded.There was no clinically significant delay and he patient remained hemodynamically stable throughout the procedure.The patient was reported as discharged.
Additional Manufacturer Narrative
An event of difficulty in delivering the device and a thrombus on the device was reported.A returned device inspection to rule out any device-related causes 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 that the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined, but the patient's tortuous anatomy may have caused the reported difficulty in delivering the device.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from the field indicated that a 5f non-abbott delivery sheath was used to deliver the device.Per the instructions for use, the minimum recommended size delivery system for use with a 12 mm avp ii plug is a 6f.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16478443
• Report Number: 2135147-2023-00997
• Device Sequence Number: 3199098
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 10/31/2025
• Device Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 7741134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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: Other
• Patient Sex: Male