BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 21831580 · Received April 11, 2025

    Report

    Report Number
    2025587-2025-02623
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 11, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: EMRE POLAT ET AL. STRATEGIC PROSTHESIS SELECTION FOR STAGED TAVI AND MINIMALLY INVASIVE MITRAL VALVE SURGERY IN A HIGH-RISK PATIENT. JACC CASE REP. MAR 19;30(6 PT 2):103234. 2025. 10.1016/J.JACCAS.2025.103234. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A 65-YEAR-OLD FEMALE PATIENT WITH SEVERE AORTIC STENOSIS WHO UNDERWENT SUCCESSFUL IMPLANT OF A MEDTRONIC EVOLUT PRO+ BIOPROSTHETIC VALVE. APPROXIMATELY SIX WEEKS LATER, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. ECHOCARDIOGRAPHY AND MULTIDETECTOR COMPUTED TOMOGRAPHY REVEALED CALCIFIC MITRAL VALVE STENOSIS WITH A MEAN GRADIENT OF 17 MM HG, CARDIOMEGALY, AND PLEURAL EFFUSION. SUBSEQUENTLY, THE PATIENT UNDERWENT MINIMALLY INVASIVE MITRAL VALVE REPLACEMENT SURGERY TO IMPLANT A MEDTRONIC HANCOCK II BIOPROSTHETIC VALVE IN THE MITRAL POSITION. DURING THE PROCEDURE THE PATIENT EXPERIENCED ISCHEMIC STROKE LIKELY DUE TO EMBOLIC DISLODGEMENT FROM THE REPEATED SURGICAL MANIPULATIONS. DESPITE THIS COMPLICATION, THE HANCOCK II BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT TRANSFERRED TO INTENSIVE CARE UNIT WITH STABLE HEMODYNAMICS. THE POST-PROCEDURAL RECOVERY WAS SIGNIFICANTLY AFFECTED BY SEVERAL COMPLICATIONS, INCLUDING WORSENING OF PRE-EXISTING CHRONIC KIDNEY DISEASE REQUIRING DIALYSIS AND RESPIRATORY ISSUES REQUIRING OXYGENATION THERAPY. DESPITE EXTENSIVE REHABILITATION EFFORTS, THE PATIENT REMAINED RELIANT ON DIALYSIS AND EXPERIENCED RESIDUAL NEUROLOGIC DEFICITS. AFTER TWO MONTHS IN THE INTENSIVE CARE UNIT, THE PATIENT WAS TRANSFERRED TO A REGULAR WARD BUT DEVELOPED A SURGICAL WOUND INFECTION IN THE GROIN AREA REQUIRING VACUUM-ASSISTED CLOSURE THERAPY BEFORE FINALLY BEING DISC HARGED FROM THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006900 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| L| H