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

Catalog Number 9-AVP2-022

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895); Separation Problem (4043)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2024, 22mm amplatzer vascular plug ii was chosen for implant into the left internal iliac artery using a 7f non- abbott delivery system.The device was properly prepared per the instructions for use (ifu).During procedure, the plug would not detach from the wire with multiple attempts of torqueing the wire counter clockwise.With continued torqueing, the wire eventually fractured leaving approximately 3cm of wire still attached to the plug.The plug was deployed in a good position in the patient body.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.

Manufacturer Narrative

An event of separation problem with multiple attempts of torquing the wire counter clockwise, and fractured wire due to continued torquing was reported.Also reported that approximately 3 cm of wire was still attached to the plug which was deployed in a good position in the patients body.A returned device assessment could not be performed as the device remains implanted and 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.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 that per the instructions for use, " if the device position is satisfactory: - attach the plastic vise to the wire, and release the device by rotating the delivery wire counterclockwise until it separates from the device.- remove the delivery catheter and wire from the patient.".

• Brand Name: AMPLATZER VASCULAR PLUG II
• Type of Device: 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: 18615452
• MDR Text Key: 334498642
• Report Number: 2135147-2024-00432
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 7425076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other