BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 1654520 · Received April 5, 2010

    Report

    Report Number
    2025587-2010-00027
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 4, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, MANY PIECES WERE RECEIVED FOR ANALYSIS. THE LARGEST WAS A SECTION THAT CONTAINED REMNANTS OF AORTIC WALL, THE PERICARDIAL PATCH AND CONDUIT SUTURED TOGETHER. A SMALLER SECTION, CONTAINING REMNANTS OF AORTIC WALL, THE PERICARDIAL PATCH, AND CONDUIT, SHOW PLEDGETS ATTACHED TO THE EXTERIOR. TWO EXCISED LEAFLETS AND A PARTIAL COMMISSURE SUTURED TO A REMNANT OF TISSUE WERE ALSO RECEIVED. REMNANTS OF COAGULATED BLOOD AND ONE PLEDGET WERE RECEIVED WITH A FEW PIECES OF POSSIBLE PERICARDIAL WALL TISSUE. THE TWO EXCISED LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE. TRACE TO MODERATE INTRACUSPAL HEMATOMAS WERE NOTED ON BOTH LEAFLETS. A LARGE TEAR ALONG THE LUNULA OF ONE LEAFLET APPEARED TO HAVE OCCURRED DURING EXPLANT. A SMALL CLUSTER OF THROMBOTIC HOST TISSUE RESTED IN THE BELLY OF ONE CUSP. A PARTIAL COMMISSURE REMAINED ATTACHED TO A REMNANT OF AORTIC WALL THAT WAS SUTURED TO AN OFF-WHITE PIECE OF TISSUE. HOST TISSUE WAS NOT OBSERVED ON THE RECEIVED PIECES EXCEPT FOR THE THROMBOTIC HOST TISSUE ON THE BELLY OF ONE LEAFLET. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN ALL EXISTING PIECES. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. DUE TO THE RECEIPT CONDITION OF THE PIECES RECEIVED FOR ANALYSIS, NO OTHER DETAILED OBSERVATION COULD BE PERFORMED. ANALYSIS WAS UNABLE TO DETERMINE THE CAUSE OF THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS BIOPROSTHETIC VALVE, DIED. IT WAS REPORTED THAT THE PATIENT HAD MARPHAN'S SYNDROME WITH AN AORTIC TYPE I DISSECTION THAT WENT DOWN TO ABDOMEN. A BENTALL PROCEDURE WAS DONE WITH A 27MM FREESTYLE AND 24 MM TUBE GRAFT. IT WAS REPORTED THAT THE PATIENT INITIALLY DID WELL. THREE MONTHS LATER, PRIOR TO A BALLOON INTERVENTION FOR A FALSE LUMEN, THE CARDIOLOGIST NOTED THAT THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT LEVELS WERE LOW. A CT SCAN OF THE PATIENT'S CHEST IDENTIFIED A HEMATOMA. THE SURGEON DETERMINED THAT SINCE THE PATIENT WAS DOING WELL, IT WAS SURMISED THAT HEALING FROM THE EXTENSIVE PROCEDURE WAS CONTINUING. THE CARDIOLOGIST PROCEEDED WITH THE FENESTRATION PROCEDURE (WHICH WAS DONE THROUGH THE SURGEON'S ACCESS SITE). ANOTHER CT SCAN OF THE CHEST WAS CONDUCTED AFTER THIS PROCEDURE AND SHOWED NO CHANGE IN THE HEMATOMA; HOWEVER, 2 DAYS LATER, THE PATIENT EXPERIENCED CHEST PAIN AND DESCRIBED HEARING A "POP." THEN THE PATIENT HAD A SYNCOPAL EPISODE. ANOTHER CT SCAN WAS DONE AND SHOWED THAT THE HEMATOMA HAD GREATLY INCREASED. A MEDIAN STERNOTOMY WAS CONDUCTED AND WHEN THE CHEST WAS OPENED, THE HEMATOMA WAS IDENTIFIED AS WELL AS BRIGHT RED BLEEDING FROM THE AORTA. A 5 MM TEAR WAS IDENTIFIED ABOUT 6MM ABOVE THE INFLOW SUTURE LINE. REPAIR WAS ATTEMPTED, BUT THE TEAR WOULD NOT HOLD THE SUTURES. AT THIS POINT, THE SURGEON TRIED CUTTING INTO THE PORCINE ROOT DOWN TO THE TEAR (AS IF TO DO ROOT ENLARGEMENT) TO TRY TO REPAIR THE VALVE WITH PERICARDIAL PATCH RECONSTRUCTION. THIS INITIALLY WORKED; HOWEVER, THE PATIENT STARTED TO BLEED FROM THE SUTURE LINE. AT THAT POINT A DECISION WAS MADE TO REMOVE THE VALVE COMPLETELY AND REPLACE IT WITH A MECHANICAL VALVE. POST-OPERATIVELY, THE PATIENT WAS TRANSFERRED TO THE ICU AND DIED APPROXIMATELY 5 HOURS LATER OF MULTI-ORGAN FAILURE. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE AORTIC ROOT BIOPROSTHESIS LWR MEDTRONIC HEART VALVES, INC. 995 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24.78 YR Death