BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 2150026 · Received July 5, 2011

    Report

    Report Number
    2015691-2011-15831
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT: NO CODE AVAILABLE FOR OBSTRUCTED CORONARY OSTIA. EVALUATION: METHOD: DEVICE WAS NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: SEVERAL ATTEMPTS WERE MADE TO RETRIEVE MORE INFORMATION FROM CUSTOMER. WITHOUT ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND PROCEDURE INFORMATION, THE ROOT CAUSE OF THE REPORTED OBSTRUCTED CORONARY OSTIA IS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. OVERALL, BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION A PRODUCT QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT. IT IS LIKELY THAT PATIENT FACTORS CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA EMAIL BY THE CUSTOMER SERVICE SPECIALIST A 3300TFX-21MM VALVE WAS EXPLANTED DUE TO LEFT CORONARY OSTIA OBSTRUCTION. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE RECEIVED OPERATIVE REPORT STATES THAT THE PATIENT HAS SYMPTOMATIC AORTIC STENOSIS. THE NATIVE VALVE WAS FIBROTIC AND CALCIFIED. THERE WAS NO NORMAL APPEARING TISSUE. THE CALCIUM CONTINUED INTO THE VENTRICULAR WALL IN ALL AREAS. THE LEAFLETS WERE EXCISED AND CALCIUM DEBRIEDED OUT OF THE WALL. THE 3300TFX WAS LOWERED IN POSITION HOWEVER SURGEON COULD NOT GET IT TO SEAT UNDER THE LEFT MAIN. THEREFORE, DECISION WAS MADE TO REMOVE THE VALVE AND REPLACED WITH A SMALLER PROSTHETIC VALVE. WHEN THIS NEW VALVE WA SUTURED IN, IT WAS FOUND THAT EACH OF THE CORONARY OSTIA WERE UNOBSTRUCTED. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS NOTED. THE PATIENT WAS TRANSPORTED TO THE SURGICAL INTENSIVE CARE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-11B0605

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R