MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number	19AHPJ-505
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/03/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2022, a 19mm sjm masters series hemodynamic plus valve was selected for implantation.Prior to the procedure the patient was reported to be stable.While implanting the valve, it was noted that the leaflets did not open and close properly.The device was removed and replaced with a new 19mm sjm masters series hemodynamic plus valve.It was noted that there was a prolonged procedure time to place the new valve.It was noted that the patient had remained hemodynamically stable throughout the procedure.After the procedure, the patient was put onto intropical support.It was reported that the patient passed away on an unknown date due to chondrogenic shock and heart failure.Due to changing the valve the patients procedure time was extended, possibly contributing to patient fatality.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Death date is an estimated date.Death date unknown.
Additional Manufacturer Narrative
An event of leaflets not opening and closing properly were reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The valve was able to rotate without difficulty.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Hydrodynamic 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 cause of the reported event could not be conclusively determined.

• Brand Name: MASTERS SERIES HEMODYNAMIC PLUS 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: 15978878
• Report Number: 2135147-2022-02546
• Device Sequence Number: 20572983
• Product Code: LWQ
• UDI-Device Identifier: 05414734005883
• UDI-Public: 05414734005883
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 03/19/2023

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 Model Number: 19AHPJ-505
• Device Catalogue Number: 19AHPJ-505
• Device Lot Number: C00001231
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2022
• 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: Death
• Patient Sex: Female