BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 24278654 · Received February 6, 2026

    Report

    Report Number
    2025587-2026-00137
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    October 13, 2025
    Report Date
    February 6, 2026
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: QUELAL ANALUISA K, ARYA N, DONISAN T, ET AL. PREDICTORS OF PERMANENT PACEMAKER IMPLANTATION FOLLOWING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT. J CARDIOVASC ELECTROPHYSIOL. 2025;36(12):3299-3309. DOI:10.1111/JCE.70139 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 THE PREDICTORS OF PERMANENT PACEMAKER IMPLANTATION (PPI) FOLLOWING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (VIV-TAVR). THE OVERALL STUDY POPULATION CONSISTED OF 261 PATIENTS WHO UNDERWENT VIV-TAVR WITH EITHER A MEDTRONIC (COREVALVE EVOLUT, EVOLUT PRO/PRO+) OR NON-MEDTRONIC (EDWARDS SAPIEN) VALVE TYPE. ONE OF THESE PATIENTS HAD A PREVIOUSLY IMPLANTED MEDTRONIC HANCOCK SURGICAL AORTIC VALVE. SEVERE AORTIC REGURGITATION WAS CITED AS THE FAILURE MECHANISM THAT PROMPTED VIV-TAVR FOR THIS HANCOCK VALVE. ADVERSE OUTCOMES ASSOCIATED WITH VIV-TAVR INCLUDED: NEED FOR PPI, MORE THAN ONE TRANSCATHETER VALVE IMPLANTED, NEED FOR INOTROPIC SUPPORT, USE OF MECHANICAL VENTRICULAR SUPPORT, AND ELEVATED MEAN GRADIENTS. DEATHS ALSO OCCURRED DURING FOLLOW-UP AFTER VIV-TAVR. HOWEVER, NO EVIDENCE WAS PRESENTED TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN A MEDTRONIC PRODUCT AND ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344635 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| L| R