BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    MDR report key: 2060345 · Received April 16, 2011

    Report

    Report Number
    2015691-2011-15247
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P000007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ADDITIONAL INFORMATION IS BEING REQUESTED BUT HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ON (B)(4) 2011, THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. ON (B)(4) 2011 THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, A CLARIFICATION OF THE ORIGINAL REPORT WAS RECEIVED. THE SURGEON STATES HE "USED THE VALVE BUT DON'T REALLY NEED THE ROOTS HENCE HE CHOPPED IT OFF. THE VALVE WAS FINE, PATIENT WAS WELL. HE SAID HE JUST WANTED YOU TO KNOW THAT THIS THING HAPPENS." THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION NOR WAS THERE AN INJURY TO THE PATIENT. THEREFORE, THIS IS NO LONGER REPORTABLE. THIS EVENT WAS REPORTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA EMAIL: "ON THE (B)(6), [SURGEON], USED A PRIMA PLUS VALVE WITH THE A TINY HOLE ON THE ROOT, HE TRIMMED IT AND USED ON THE PATIENT. ACCORDING TO [SURGEON], THE PATIENT WAS WELL , EXTUBATED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION REGARDING THE EVENT OR THE PATIENT WAS MADE AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, OUR SALES REP RECEIVED CLARIFICATION FROM THE HEALTH CARE PROVIDER THAT THERE WAS NO ISSUE WITH THE DEVICE AS PREVIOUSLY REPORTED. THE SURGEON "TRIMMED" THE DEVICE TO BETTER FIT THE PATIENT AND THE RESPONSE STATED "DON'T REALLY NEED THE ROOTS HENCE HE CHOPPED IT OFF. THE VALVE WAS FINE, PATIENT WAS WELL." HIS ORIGINAL REPORT WAS FOR INFORMATION PURPOSES ONLY AND WAS NOT A COMPLAINT OR A REPORT OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2500P R-08B035

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R