MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Catalog Number 21AGFN-756

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/18/2023

Event Type  Injury  

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 21mm sjm regent heart valve was successfully implanted in a 55-year-old patient due to severe aortic regurgitation.On (b)(6) 2023 the patient went to the hospital for follow-up consultation and found that the opening and closing of the valve leaflets was restricted by ultrasonography, severe aortic regurgitation, and moderate mitral regurgitation was occurring.So the doctor decided to perform a second operation to replace the valve of the same type on (b)(6) 2023, a 21mm sjm regent heart valve was implanted.The procedure was completed and the patient was in stable condition.The patient was put on warfarin and aspirin post implant with latest international normalized ratio (inr) was 2.5.

Manufacturer Narrative

An event of the valve abnormally coapting and explant was reported.The device was received for examination and no anomalies were found.The valve was sent for functional testing which confirmed that the valve functioned normally, with the leaflets moving with no asynchronous motion.It was noted that severe aortic regurgitation, and moderate mitral regurgitation was present which can lead to tenting and poor coaptation of the leaflets.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 the reported event could not be conclusively determined.

Event Description

N/a.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18038807
• MDR Text Key: 326964575
• Report Number: 2135147-2023-04784
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 30343618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 72 KG