BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2150463 · Received June 7, 2011

    Report

    Report Number
    9612164-2011-00536
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED. THE HYPOTUBE WAS SLIGHTLY BENT. THERE WAS BLOOD RESIDUE PRESENT ALONG THE DISTAL SHAFT AND BETWEEN THE BALLOON FOLDS. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE FIFTH, SIXTH, SEVENTH, EIGHTH AND NINTH PROXIMAL STENT SEGMENTS WERE RAISED, DAMAGED AND DEFORMED. THE TENTH PROXIMAL STENT SEGMENT WAS SLIGHTLY RAISED. NO FURTHER DAMAGE WAS NOTED. A PROTECTIVE SHEATH COULD NOT BE PLACED OVER THE STENT DUE TO THE RAISED STENT STRUTS. THE PROXIMAL, MID AND DISTAL STENT OUTER DIAMETERS MET SPECIFICATION REQUIREMENTS BUT THE 7TH PROXIMAL STENT DID NOT. (B)(4). EVALUATION, RESULTS: (FAILURE TO DELIVER THE STENT, STENT DEFORMATION), RESULTS AND CONCLUSIONS: (TORTUOUS VESSEL WITH HIGH CALCIFICATION), (Y ADAPTOR).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) CORONARY STENT SYSTEM DIAMETER 2.5 MM LENGTH 24MM TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. THE LESION HAS BEEN PRE-DILATED. THE PHYSICIAN WAS ATTEMPTING TO PERFORM A KISSING STENT DEPLOYMENT AND PRIOR TO THE 2.5 X 24 ENDEAVOR DELIVERY AN ENDEAVOR SPRINT RX CORONARY STENT SYSTEM DIAMETER 2.5MM LENGTH 14MM WAS ALREADY POSITIONED AT THE LESION. FOLLOWING A FAILURE TO CROSS THE LESION RESISTANCE WAS NOTED WHILE RETRACTING THE DEVICE THROUGH THE Y-ADAPTOR. WHEN THE STENT WAS BROUGHT OUT THROUGH THE Y ADAPTER SOME RESISTANCE WAS NOTED. UPON INSPECTION, THE STENT SHOWED SOME IRREGULARITY AND WAS DEEMED NOT USABLE. MULTIPLE PRE-DILATIONS WERE AGAIN PERFORMED ON THE LESION AND ANOTHER ENDEAVOR STENT WAS SUCCESSFULLY DEPLOYED AT THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005389482

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK