MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG 4; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number 9-AVP038-004

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

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

Event Date 10/05/2023

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 a 4mm amplatzer vascular plug iv was selected for implant on 05 (b)(6) 2023 to treat cardiac malformation.During implant, the device took on a deformed shape, with the distal part of the plug wider than the proximal part.It was observed the second lobe was unable to deploy.The device was removed from the patient prior to release from the delivery system.It was noted that the device was replaced with a new unknown device.The intervention time was reported to be less than 30 minutes.There was no adverse effects to the patient.

Manufacturer Narrative

An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional and visual specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.No other complaints were reported on the batch.The cause of the reported event could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG 4
• 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: 18093357
• MDR Text Key: 328240171
• Report Number: 2135147-2023-04923
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806012346
• UDI-Public: 00811806012346
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-AVP038-004
• Device Lot Number: 8986847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• 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): Required Intervention