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

Model Number 19AGN-751

Device Problem Fracture (1260)

Patient Problem Hemoptysis (1887)

Event Date 11/14/2022

Event Type  Death  

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) 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 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.

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
• 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: 16039925
• MDR Text Key: 306060182
• Report Number: 2135147-2022-02697
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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): Death
• Patient Sex: Female