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

Model Number	AGFN-756
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 19mm sjm regent¿ mechanical heart valve (flexcuff¿), was implanted.Prior to implant, the leaflets were moving normally when tested at the time of device preparation with plastic surgical instruments and physiological saline were used to test leaflet function.After surgery, it was found that the valve leaflet did not open and close properly when tested with plastic surgical instruments and physiological saline.The valve was explanted and replaced with another 19mm sjm regent¿ mechanical heart valve (flexcuff¿), which was successfully implanted.Post-explant of the first device, the valve was tested, but the leaflet did not move normally.The patient took warfarin after procedure and latest inr is 2.5.The patient remain stable.
Additional Manufacturer Narrative
The reported event of valve leaflets not opening and closing normally after implant could not be confirmed.Information from the field indicated that the valve was initially tested using plastic surgical instruments.Investigation found no anomalies on the valve leaflets, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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 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.Please note per the instructions for use, artmt600080902 rev.B."using the st.Jude medical¿ leaflet tester, open the valve and inspect the area for any obstructive tissue.If visualization is inadequate, use the st.Jude medical¿ leaflet tester to confirm free leaflet motion.Warning: do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications.".

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: 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: 16954204
• Report Number: 2135147-2023-02186
• Device Sequence Number: 3340081
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2025
• Device Model Number: AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 7372650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 67 KG