BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1844415 · Received September 24, 2010

    Report

    Report Number
    2015691-2010-14116
    Event Type
    Death
    Date Received
    September 24, 2010
    Date of Event
    June 15, 2010
    Report Date
    September 2, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2010 DUE TO MITRAL STENOSIS. IT WAS ALSO LEARNED THAT THE PATIENT EXPIRED ON (B)(6) 2010 FROM RIGHT HEART FAILURE AND PULMONARY HYPERTENSION. PER THE OPERATIVE REPORT OF (B)(6) 2010, THE PATIENT HAD "...SEVERE MITRAL STENOSIS ACROSS A STENOTIC PORCINE PROSTHESIS AND THERE WAS MILD TO MODERATE AORTIC REGURGITATION. TRICUSPID REGURGITATION WAS SEVERED." THEREFORE, A MVR, AVR, AND A TRICUSPID ANNULOPLASTY PERFORMED. "SEPARATION FROM BYPASS WAS ACHIEVED BUT ALTHOUGH THE LEFT SIDE OF THE HEART WAS VIGOROUS AND CONTRACTING WELL, THE RIGHT SIDE REMAINED ESSENTIALLY NON-MOVING WITH SIGNIFICANT PULMONARY HYPERTENSION. THERE WAS NO TRICUSPID REGURGITATION. AFTER A MIXTURE OF INOTROPES, AN INFUSION OF ADRENALIN AND NORADRENALINE TOGETHER WITH DOBUTAMINE AND NITRIC SHE WAS TRANSFERRED ONTO THE BED. SHORTLY AFTER THIS HER PRESSURES DETERIORATED REQUIRING INCREASING AMOUNTS OF INOTROPE AND IT WAS CLEAR THAT THE RIGHT SIDE OF HER HEART WAS TOTALLY NON-FUNCTIONING DESPITE ALL RESUSCITIVE MEASURES. SHE CONTINUED TO DETERIORATE AND DECEASED IN THE OPERATIVE THEATRE AT APPROXIMATELY 1710 HOURS. THE CORONER WAS INFORMED."

    Additional Manufacturer Narrative · 1

    ON 12/01/2010, THE SALES REP TALKED TO THE CLINICAL NURSE AND WAS TOLD THE DEVICE HAD BEEN DISCARDED. THEREFORE, THE DEVICE WILL NOT BE RETURNED AND NO EVALUATION OF THE DEVICE WILL BE DONE. STENOSIS IS THE REASON FOR EXPLANT OF THE MITRAL VALVE. STENOSIS CAN BE DUE TO MANY FACTORS DEPENDING ON THE IMPLANT DURATION INCLUDING, BUT NOT LIMITED TO: CALCIFICATION, THROMBOSIS AND PANNUS. WE, UNFORTUNATELY, ARE UNABLE TO EVALUATE THE DEVICE TO DETERMINE THE ROOT CAUSE OF THE STENOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED, (B)(4). TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA E-MAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF 43.5 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED TWO OVERLAPPING CYPHER STENTS IN THE RIGHT CORONARY ARTERY. THREE AND A HALF YEARS AFTER THE INDEX PROCEDURE THE PATIENT CAME IN FOR ADDITIONAL TREATMENT AND THE PHYSICIAN FOUND STENT FRACTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 04H047

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death