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

Model Number	9-AVP2-014
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
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)2022, a 14mm amplatzer vascular plug ii (avp2) was chosen for implant.In order to repair a leak in the internal iliac artery (iia), and to prevent type 2 endoleak as a complication of endovascular aneurysm repair (evar), the right iia embolism site was approached from the left common femoral artery with a 6f non-abbott (terumo destination) guiding sheath crossover.The 14mm avp2 was inserted into the guiding sheath and a delivery was attempted.It was abandoned due to strong resistance near the right common iliac artery.There was no attempt to release the device at this time.The avp2 was replaced with a penumbra manufactured coil.The penumbra manufactured coil was changed to a 0.035" pod coil and the right iia was successfully embolized.The physician suggested, based on experience, that the problem may lie with the specific avp2 used.There were no adverse patient effects.
Additional Manufacturer Narrative
An event of difficulty in delivering the device was reported.A returned device 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.Information from the field indicated that a 6f 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 14 mm avp ii plug is an 8f.

• 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: 15977384
• Report Number: 2135147-2022-02540
• Device Sequence Number: 5784413
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: 00811806010403
• 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): 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 8582306
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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
• Patient Sex: Male