BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 8038326 · Received November 5, 2018

    Report

    Report Number
    2025587-2018-02951
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    October 16, 2018
    Report Date
    May 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    10681490265918
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: DALLAN LAP ET AL. PREDICTED CORONARY OCCLUSION AND IMPELLA SALVAGE DURING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT. CARDIOVASC REVASC MED. 2019 MAR 29. PII: S1553-8389(19)30223-4. DOI: 10.1016/J.CARREV.2019.03.019. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION VIA LITERATURE REGARDING THIS (B)(6) FEMALE PATIENT WHO PRESENTED WITH PROGRESSIVE DYSPNEA ON EXERTION, LOWER LIMB EDEMA, AND NYHA III HEART FAILURE. IN ADDITION TO THE SURGICAL AORTIC VALVE REPLACEMENT, THE PATIENT HAD A HISTORY OF CARDIAC ARREST WITH PERMANENT PACEMAKER IMPLANTATION AND PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY (RCA) SEVEN YEARS PRIOR, AND MYOCARDIAL REVASCULARIZATION SURGERY (GRAFT FOR RCA) IN FIVE YEARS PRIOR DUE TO RCA INTRA-STENT RESTENOSIS (ISR) WITH REFRACTORY ISCHEMIA AND CHRONIC KIDNEY DISEASE. DUE TO THE MULTIPLE COMORBIDITIES, THE HEART TEAM DECIDED TO PERFORM VALVE-IN-VALVE (VIV) WITH A TRANSCATHETER AORTIC VALVE IMPLANT (TAVI).

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMMON PROBABLE CAUSE FOR STENOSIS IS DUE TO PANNUS OVERGROWTH. THIS FINDING IS GENERALLY CONSIDERED A PATIENT-RELATED CONDITION. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 18 YEARS AND 8 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880479 FREESTYLE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION FR99525 10681490265918

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention