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

Model Number 9-AVP2-022

Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, an 22mm amplatzer vascular plug ii was chosen for implant with a non-abbott delivery system.It was reported the plug exhibited an "elongating" abnormal shape during deployment.The device was recaptured and repositioned but maintained its elongation shape.A decision was made to continue with the procedure and the device was implanted in the patient.The physician could not confirm if the elongation shape was due to patient anatomy.The patient remained hemodynamically stable throughout the procedure and their status was reported as stable.There was no report of any interaction with cardiac structures during deployment or any angulation/kink noticed with the delivery system.

Manufacturer Narrative

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

Manufacturer Narrative

An event of device deformity during deployment was reported.A returned device assessment could not be performed as the device was not returned for analysis.Possible causes of device deformity include use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment.Information from the field indicated that there were no kinks noticed in the delivery system and there was no interaction with cardiac structures during the deployment.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.The field indicated that the device was implanted in it's elongated state.Please note per the instructions 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.

• 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: 16516615
• MDR Text Key: 311041096
• Report Number: 2135147-2023-01092
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806010441
• UDI-Public: 00811806010441
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-AVP2-022
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 7935892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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