BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1962233 · Received January 17, 2011

    Report

    Report Number
    2015691-2011-14695
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO DEVICE RETURN. DEVICE REMAINS IMPLANTED. ADDITIONAL MANUFACTURER NARRATIVE: IN A FOLLOW UP CALL WITH THE SURGEON ON (B)(6) 2010, THE FOLLOWING INFORMATION WAS PROVIDED: [DOCTOR] ADVISED THAT HE OBSERVED A "LOOSE, WHITE, STRINGY, FIBROUS" PIECE OF MATERIAL WHEN IMPLANTING THE DEVICE. THE MATERIAL WAS LOCATED UPON "VIEWING THE UNDERSURFACE ON THE ROUGH SIDE" OR INFLOW ASPECT OF THE VALVE. THE LEAFLETS WERE GENTLY DISPLACED TO CHECK SUTURE AND PLEDGET PLACEMENT PRIOR TO SEATING THE VALVE. THE MATERIAL WAS OBSERVED "APPROXIMATELY 1MM FROM THE TOP, ALONG THE TOP OF THE LEAFLET." THE VALVE HAS BEEN RINSED PER IFU INSTRUCTIONS TWICE PRIOR TO INITIATING IMPLANT AND WAS NOTED TO BE APPROXIMATELY TWO MONTHS PRIOR TO THE LABELED EXPIRATION DATE. IT WAS CONFIRMED THAT THIS IS THE PROPER RINSE PROCESS AND THAT THE TIME TO EXPIRATION WAS INCONSEQUENTIAL. [DOCTOR] PULLED THE MATERIAL TO REMOVE IT FROM THE VALVE, BELIEVING IT TO POSSIBLY BE FAT OR ADVENTITIAL TISSUE. HE FELT RESISTANCE SIMILAR TO REMOVING A STRING; ADVISED THAT HE WAS NOT CONCERNED AS IT APPEARED TO BE ALONG THE ROUGH SIDE, EDGE OF THE LEAFLET. NOTHING ELSE APPEARED LOOSE OR REMARKABLE. [DOCTOR] NOTED THAT THE PATIENT IS DOING WELL AND TEE LOOKED PERFECT. THE OPERATIVE REPORT AND/OR DISCHARGE SUMMARY AND TEE WERE REQUESTED, BUT HAVE NOT BEEN RECEIVED. THE PARTICULATE REMOVED FROM THE DEVICE WAS NOT SAVE BY THE HOSPITAL AND IS THEREFORE NOT AVAILABLE FOR ANALYSIS AND EVALUATION. THE DEVICE CANNOT BE EVALUATED AS IT REMAINS IMPLANTED. 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

    THE SALES REP RECEIVED THE FOLLOWING REPORT FROM THE SURGEON VIA EMAIL: [THE SURGEON] HAD IMPLANTED A DEVICE AND AFTER ALL THE SUTURES WERE TIED AND HE WAS CHECKING THE PLEDGETS BELOW, HE NOTED A STRINGY PIECE OF MATERIAL LINED AT THE TOP OF TWO OF THE LEAFLETS. HE WAS ABLE TO PULL IT OFF. HE EXAMINED THE REST OF THE VALVE AND DID NOT SEE ANY DEFECTS. HE DECIDED AT THAT TIME TO LEAVE THE VALVE IMPLANTED AND CAME OFF BYPASS WITH NO ISSUES. VALVE LEAFLETS APPEARED TO FUNCTION NORMALLY ON ECHO AT THE END OF THE PROCEDURE.

    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-09K2374

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R