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

Catalog Number	19AHPJ-505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm epic plus supra was implanted in a patient.On (b)(6) 2023, the device was explanted due to a paravalvular leak of 8 mmhg and average gradient of 35 mmhg.A 19mm sjm masters series hemodynamic plus valve was implanted as a replacement.Post implant, it was reported that the patient passed away.The cause and date of the death is unknown.
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 epic plus supra was implanted in a patient.On (b)(6) 2023, the device was explanted due to a paravalvular leak of 8 mmhg and average gradient of 35 mmhg.A 19mm sjm masters series hemodynamic plus valve was implanted as a replacement.Post implant, it was reported that the patient passed away.The cause and date of the death is unknown.
Additional Manufacturer Narrative
B2 - date of death is estimated.An event of death post valve replacement was reported.Information from the field indicated that the reason for the explant and valve replacement was an elevated mean transvalvular gradient of 35 mmhg and a paravalvular leak.Based on the information received, the cause of death could not conclusively be determined but is most likely procedure related.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18013991
• Report Number: 2135147-2023-04703
• Device Sequence Number: 12649485
• 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
• 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): 12/19/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 19AHPJ-505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Life Threatening; Death
• Patient Age: 67 YR
• Patient Sex: Female