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

Model Number	21AGN-751
Medical Device Problem Codes	Fracture (1260); Incomplete Coaptation (2507); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2022, a 21mm regent mechanical heart valve was implanted in the aortic position due to ascending aorta aneurysm and aortic valve disease.During implant, it was noted that one of leaflet's motion was restricted.The physician used the holder handle to attempt to rotate the valve but it was not possible.The surrounding area of the valve was checked for any interfering tissue, but interferences were reported.The procedure was completed.After implantation, one of the leaflets was working perfectly but the other one was not moving freely.Because there was no interference noted, the physician thought that the leaflet would achieve free movement with the natural heart movement.Immediately post procedure, a central echocardiogram (echo) was performed and increased gradient was noted.An angiography was performed, and it was noted that one leaflet was not moving freely.It was decided to explant the valve.During explant procedure on (b)(6) 2022, it was noted again that the leaflet was still not moving.Upon explant examination the leaflet broke.A new 23mm masters mechanical heart valve was successfully implanted.Patient was reported to be in stable condition.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of one leaflet not moving, inability to rotate the valve, and then the leaflet fracturing during examination was reported.The investigation found that a leaflet was fractured, however the valve rotated freely.The leaflet which was intact in the orifice moved with ease.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture design or labeling.

• Brand Name: REGENT HEART VALVE
• 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: 14073809
• Report Number: 2135147-2022-00149
• Device Sequence Number: 17647226
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/27/2022

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 Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 8301137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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 Sex: Female