BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 2770533 · Received October 3, 2012

    Report

    Report Number
    2025587-2012-00152
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    January 31, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED SO DEVICE HISTORY REVIEW WAS UNABLE TO BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE APPEARED DISTORTED; OVAL SHAPED. ALL LEAFLETS WERE STIFF DUE TO VEGETATIVE HOST TISSUE ON THE INFLOW AND OUTFLOW. TISSUE DEGENERATION WAS OBSERVED ON ALL LEAFLETS. A TEAR WAS NOTED IN THE BELLY OF THE LEFT CUSP. ALL COMMISSURES WERE INTACT. TAN TO BROWN VEGETATIVE APPEARING HOST TISSUE, CONSISTENT WITH HISTORICAL EVENTS FOR ENDOCARDITIS, FILLED AND STIFFENED ALL LEAFLETS ON THE INFLOW AND OUTFLOW. RADIOGRAPHY SHOWED A THIN STRIP OF MINERALIZATION ALONG THE RIGHT CUSP FREE MARGIN. CONCLUSION: THERE WAS NO REPORT OF INFECTION OR ENDOCARDITIS RECEIVED. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED TAN TO BROWN VEGETATIVE APPEARING HOST TISSUE THAT FILLED AND STIFFENED ALL LEAFLETS ON THE INFLOW AND OUTFLOW, WHICH IS CONSISTENT WITH HISTORICAL EVENTS FOR ENDOCARDITIS. THERE WAS A TEAR IN THE LEFT CUSP WHICH LIKELY CAUSED THE REPORTED CENTRAL REGURGITATION AND WAS LIKELY DUE TO LEAFLET STIFFENING SECONDARY TO ENDOCARDITIS. THE SOURCE OF THE NOTED INFECTION/ENDOCARDITIS IS UNKNOWN. RADIOGRAPHY SHOWED A THIN STRIP OF MINERALIZATION ALONG THE RIGHT CUSP FREE MARGIN. THIS FINDING IS GENERALLY CONSIDERED A PATIENT RELATED CONDITION. REVIEW OF THE DEVICE HISTORY RECORD AND STERILITY LOT SHOWS THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED TO DISTRIBUTION. NO ISSUES WERE NOTED THAT WOULD HAVE IMPACTED THIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SINCE THE INITIAL MEDWATCH REPORT WAS SUBMITTED, ADDITIONAL INFORMATION WAS RECEIVED THAT TWO YEARS AND SIX MONTHS FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, ECHOCARDIOGRAPHY REVEALED CENTRAL REGURGITATION, PEAK GRADIENT OF 50 MMHG AND EOA 0.5 CM SQUARED. THE VALVE WAS EXPLANTED AND REPLACED WITH A PERICARDIAL VALVE. IT WAS ALSO NOTED THAT THERE WAS CALCIFICATION AND THROMBUS ON THE VALVE. THE VALVE WILL BE RETURNED TO MEDTRONIC. PATIENT INFORMATION, IMPLANT DATE, CATALOG NUMBER, SERIAL NUMBER, EXPIRATION DATE, MANUFACTURE DATE, PATIENT AND DEVICE CODES HAVE BEEN UDPATED ON THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND EVALUATED. (B)(6). (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 APPROXIMATELY TWO YEARS FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED DUE TO VALVE DEGENERATION. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention