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

Catalog Number 9-AVP2-018

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 02/21/2024

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, a 18mm amplatzer vascular plug 2 was implanted in a patient.During the procedure, it was noted that a bulbous deformation occurred.The device was not removed from the delivery system while inside the patient.There was no interaction with cardiac structures during deployment.There were no angulations or kink noted in the delivery system.The device was removed but not replaced.The patient's status was noted as recovery.No device was ultimately implanted.No adverse consequences were experienced related to this event.The healthcare professional did not believe that the patient or user experienced adverse health consequences due to the performance of the product.

Manufacturer Narrative

An event of device deformity was reported.The investigation confirmed the device met functional specifications when analyzed at abbott.Examination of the plug revealed one small hole in the side of the device waist.The hole is considered a normal and acceptable characteristic of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19026283
• MDR Text Key: 339207105
• Report Number: 2135147-2024-01481
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806010427
• UDI-Public: (01)00811806010427(17)271130(10)8812006
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K071699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 9-AVP2-018
• Device Lot Number: 8812006
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2022
• 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