BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    MDR report key: 3133802 · Received May 29, 2013

    Report

    Report Number
    2015691-2013-20181
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P000007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CUSTOMER REPORT OF REGURGITATION COULD NOT BE CONFIRMED. LEAFLET PIECES DID NOT APPEAR TO HAVE CALCIFICATION OR HOST TISSUE. METHOD: X-RAY. THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. SINCE THE DEVICE WAS RETURNED INCOMPLETE, WE ARE UNABLE TO GET THE SERIAL NUMBER FROM THE DEVICE. THEREFORE, NO DEVICE HISTORY RECORD (DHR) REVIEW CAN BE DONE. THE FOLLOWING ADDITIONAL INFORMATION WAS LEARNED THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER: THE PATIENT CONDITION WAS REPORTED TO BE ¿RECOVERED¿. THE CUSTOMER COMMENTED THAT THIS EXPLANT WAS WITHIN EXPECTATION BUT DID NOT ELABORATE ON FURTHER CONDITION OF THE DEVICE AT TIME OF PROCEDURE. THE VALVE REMAINS IMPLANTED, ONLY THE LEAFLETS WERE REMOVED AND RETURNED. THE ECHO REPORT WILL NOT BE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO EXPLAIN REMOVAL OF THE LEAFLETS. WITHOUT RETURN OF THE COMPLETE DEVICE OR ADDITIONAL INFORMATION FROM THE HEALTH CARE PROVIDER, WE ARE UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    REPORTEDLY, LEAFLETS OF A 23MM STENTLESS VALVE WERE RESECTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS DUE TO AORTIC REGURGITATION (AR). THE CUSTOMER REPORTED THAT A 23MM STENTLESS BIOPROSTHESIS WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) BY MODIFIED SUBCORONARY TECHNIQUE TO CORRECT AORTIC STENOSIS (AS) AT ANOTHER HOSPITAL IN 2007. FROM 2010, AORTIC REGURGITATION WAS OBSERVED. ON (B)(6) 2013, THE LEAFLETS OF THE VALVE WERE RESECTED AND A MAGNA EASE VALVE, MODEL 3300TFX21MM (S/N: (B)(4)), WAS IMPLANTED IN A BENTALL SURGERY WITH A (B)(4) LIFELINE¿S J GRAFT (26MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234730 EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2500P 06C104

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R