BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2191561 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00773
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: STENT DAMAGE, FAILURE TO DELIVER THE STENT. RESULTS/CONCLUSIONS: TARGET LESION EXHIBITED MODERATE CALCIFICATION AND 80% STENOSIS FOLLOWING PRE-DILATION. DEVICE EVAL: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN MARKER BANDS AS PER SPEC. THE FIRST NINE PROXIMAL STENT SEGMENTS AND THE FIRST THREE DISTAL STENT SEGMENTS WERE INTACT. THE REMAINING MID STENT SEGMENTS WERE SEVERELY BUNCHED AND DEFORMED. THE DISTAL TIP WAS DAMAGED. THE PROTECTIVE SHEATH WAS LOADED ON THE DEVICE. THE DISTAL END OF THE SHEATH WAS TORN AND BUNCHED. THE BALLOON FOLDS ON THE PROXIMAL PILLOW WERE PARTIALLY OPENED AND DEFORMED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.5 MM DIAMETER X 30 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN THE LCX WITH 85% STENOSIS AND MODERATE CALCIFICATION. AN ATTEMPT WAS MADE TO DELIVER THE ENDEAVOR SPRINT STENT, HOWEVER THE STENT COULD NOT CROSS THE LESION AND WAS REMOVED. THE TARGET LESION WAS PRE-DILATED TWICE USING A 1.5 X 20 MM SPRINTER LEGEND RX BALLOON UP TO 12 ATMS. EIGHTY PERCENT STENOSIS REMAINED FOLLOWING PRE-DILATION. A SECOND ATTEMPT WAS THEN MADE TO DELIVER THE ENDEAVOR SPRINT STENT USING A DOUBLE GUIDEWIRE FOR SUPPORT. THE DEVICE COULD NOT CROSS THE LESION AND WAS REMOVED. STENT STRUTS WERE OBSERVED TO BE DAMAGED ON REMOVAL. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE TARGET LESION WAS TREATED USING A DIFFERENT SIZE STENT. PT STATUS POST PROCEDURE WAS REPORTED TO BE STABLE AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005314359

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK