BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 15352374 · Received September 2, 2022

    Report

    Report Number
    2025587-2022-02456
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    April 22, 2022
    Report Date
    September 2, 2022
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ALNSASRA ET AL. EMBOLISATION OF A PROSTHETIC MITRAL VALVE FRAGMENT DURING VALVE-IN-VALVE TRANSCATHETER MITRAL VALVE IMPLANTATION. EUROINTERVENTION. 2022 APR 22;17(18):1534-1535. DOI: 10.4244/EIJ-D-21-00630. 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A 76-YEAR-OLD FEMALE PATIENT WHO FIVE YEARS PRIOR WAS IMPLANTED WITH A NON-MEDTRONIC BIOPROSTHETIC AORTIC VALVE AND A MEDTRONIC HANCOCK II BIOPROSTHETIC MITRAL VALVE (NO UNIQUE DEVICE IDENTIFIER PROVIDED). THREE YEARS AFTER THE IMPLANT SHE HAD INFECTIVE ENDOCARDITIS WITH SMALL VEGETATIONS ATTACHED TO THE MITRAL VALVE WHICH WERE TREATED SUCCESSFULLY WITH ANTIBIOTIC THERAPY WITHOUT RESIDUAL VALVULAR DYSFUNCTION. TWO YEARS LATER, SHE DEVELOPED SEVERE SYMPTOMATIC MITRAL REGURGITATION (MR) WITHOUT EVIDENCE OF ACTIVE INFECTION. CURRENTLY SHE PRESENTED WITH ACUTE HEART FAILURE DECOMPENSATION. DUE TO HER COMORBIDITIES THE HEART TEAM DEEMED HER HIGH RISK AND RECOMMENDED VALVE-IN-VALVE TRANSCATHETER MITRAL VALVE IMPLANTATION. INTRAPROCEDURAL TRANSOESOPHAGEAL ECHOCARDIOGRAM (TOE) CONFIRMED SEVERE MR DUE TO A FLAIL LEAFLET OF THE BIOPROSTHETIC VALVE. VIA TRANSSEPTAL ACCESS, A NON-MEDTRONIC BIOPROSTHETIC MITRAL VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE HANCOCK II BIOPROSTHETIC VALVE WITH MILD MR AND NO PARAVALVULAR LEAK. OF NOTE, A PORTION OF THE LEAFLET THAT WAS INITIALLY NOTED HAD BROKEN FREE AND WAS CAPTURED BY A CEREBRAL PROTECTION SYSTEM. THE POST-PROCEDURAL COURSE WAS UNEVENTFUL WITH NO NEUROLOGICAL DEFICITS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367850 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA T510

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Life Threatening| H| R