BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 3864282 · Received June 10, 2014

    Report

    Report Number
    2025587-2014-00367
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED AND THEREFORE NOT RETURNED FOR ANALYSIS. INVESTIGATION CONCLUSION: BASED ON THE RECEIVED INFORMATION, THE CAUSE OF THE REGURGITATION AND HIGH GRADIENT IS DUE TO PATIENT PROSTHESIS MISMATCH (PMM).

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC TISSUE VALVE EXHIBITED MILD TO MODERATE CENTRAL AORTIC INSUFFICIENCY AND A HIGH GRADIENT MEASUREMENT 56 MONTHS AFTER IMPLANT. A PERCUTANEOUS AORTIC VALVE (PAV) WAS IMPLANTED VALVE-IN-VALVE, WHICH REDUCED BUT DID NOT RESOLVE THE GRADIENT. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS CONDUCTED TO POST-DILATE THE PAV, WHICH ALSO REDUCED BUT DID NOT RESOLVE THE GRADIENT. IT WAS THEN DETERMINED THAT THERE WAS A PATIENT-PROSTHESIS MISMATCH OF THE BIOPROSTHETIC VALVE, AND THAT A MORE OPTIMAL RESULT WOULD NOT BE POSSIBLE. BOTH VALVES REMAIN IMPLANTED, AND NO ADDITIONAL INTERVENTION WAS PERFORMED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337641 MOSAIC HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305U23

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention