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

Catalog Number	21AGFN-756
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
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 21mm regent aortic mhv,flex c uff was selected for an implant.During the procedure, the holder handle was fully inserted into the orifice at a 90 degree angle and there was no resistance felt when rotating the valve.The valve fractured inside the patient at the time of implantation and was recovered from the patient.Device had to be replaced by another 19mm regent aortic mhv,flex c uff.No anatomical damage is reported in the patient.The patient is stable.
Additional Manufacturer Narrative
An event of a dislodged leaflet was confirmed.The device was returned to abbott for investigation; one leaflet was dislodged and fractured, and the other leaflet remained properly inserted into the orifice.There was no evidence of material defect in the carbon coating that may have caused or contributed to the fractured leaflet.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all defined manufacturing specifications.The cause of the reported event could not be conclusively determined but is consistent with some external force being applied to the valve, which overstressed the carbon material.There is no indication of a product quality issue with regard to manufacture, design, or labeling.

• 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: 17436134
• Report Number: 2135147-2023-03351
• Device Sequence Number: 20541705
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: C00010774
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG