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

Model Number	9-AVP2-018
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
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 a 18mm amplatzer vascular plug ii was chosen for procedure.During the procedure, an attempt to advance the device through a 7fr sheath was made and the user reported feeling resistance.The sheath was exchanged with a larger 8fr sheath and the device was able to be deployed.The user repositioned and re-sheathed the device 3 to 4 times.During the last attempt to deploy this device, while inside the patient, the device presented with a deformation on one of the discs, its shape unspecified.Still attached to the cable, the device was removed and exchanged with an unknown size avpi device and the procedure was successful.The patient did remain stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information has been provided.
Additional Manufacturer Narrative
An event of advancement difficulty and device deformation was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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.Please note, per the amplatzer vascular plug ii instructions for use, "directions for use: if device position is unsatisfactory: stabilize the wire and re-advance the delivery catheter until the device is completely within the catheter.Reposition and deploy, or remove the device from the patient." d6a & d6b: added implant & explant date.H6: medical device problem code added: 2920 difficult to advance.

• 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: 13638446
• Report Number: 2135147-2022-00069
• Device Sequence Number: 5075630
• Product Code: KRD
• UDI-Device Identifier: 00811806010427
• UDI-Public: 00811806010427
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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 Expiration Date: 05/31/2024
• Device Model Number: 9-AVP2-018
• Device Catalogue Number: 9-AVP2-018
• Device Lot Number: 7031403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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: Unknown