MAUDE Adverse Event Report: ABBOTT MEDICAL ATTUNE FLEXIBLE ADJUSTABLE ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number AFR-33

Device Problem Material Separation (1562)

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

Event Date 03/29/2023

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 on (b)(6) 2023, a 33mm attune ring was chosen for implant.After the ring was placed, the physician attempted tightening the suture and the suture broke.The ring was replaced with an unknown size epic valve.The patient was reported as recovering.

Manufacturer Narrative

An event of broken thread of suture on the ring was confirmed.The device was returned to abbott for investigation and the ring was grossly examined and one of the suture threads was torn/ripped at the end.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported incident could not be conclusively determined, however may have occured while attempting to implant the device, consistent with damage during use.

• Brand Name: ATTUNE FLEXIBLE ADJUSTABLE ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16800796
• MDR Text Key: 313918334
• Report Number: 2135147-2023-01792
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734029995
• UDI-Public: 05414734029995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092876
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFR-33
• Device Catalogue Number: AFR-33
• Device Lot Number: 8609427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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