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

Model Number	19AGN-751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemoptysis (1887)
Date of Event	11/14/2022
Type of Reportable Event	Death
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) 2022, a 19mm sjm regent heart valve was selected for implantation.During the procedure, when the device was rotated to position the valve.There was notable resistance felt while rotating.It was then noted that the device was fractured near the annulus of the patient.The valve was then replaced with another 19mm sjm regent heart valve to resolve the event.The patient remained hemodynamically stable throughout the procedure.The replacement of the valve caused a delay of approximately 40 minutes.12 hours following the procedure, low cardiac output was noted and the patient was placed on ecmo.The patients hemodynamics and ejection fraction (ef) values improved.On (b)(6) 2022, the patient passed away due to hemoptysis.It is believed that prolonged bypass and cross-clamp time during the procedure contributed towards patient death.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was reported that the 19mm sjm regent heart valve was selected for implantation for an aortic valve replacement procedure.The leaflets on the fractured device did not dislodge.The valve was then replaced with another 19mm sjm regent heart valve to resolve the event.12 hours following the procedure, low cardiac output was noted and the patient was placed on ecmo.The patients hemodynamics and ejection fraction (ef) values improved.It was noted that massive hemoptysis was observed.On (b)(6) 2022, the patient passed away.The cause of death was noted to have been due to low cardiac output due to prolonged bypass and cross-clamp time during the procedure.
Additional Manufacturer Narrative
An event of notable resistance felt when rotating the valve during procedure, device fracture causing delayed procedure, low cardiac output, massive hemoptysis and patient death was reported.The investigation found the orifice of the valve was chipped.The valve rotated freely with no resistance noted upon return to abbott.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 device fracture could not be conclusively determined, however is consistent with rotating the valve through resistance.

• 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: 16039925
• Report Number: 2135147-2022-02697
• Device Sequence Number: 17696888
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• 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): 03/20/2023

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: 11/10/2025
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 7737031
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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: Death
• Patient Sex: Female