BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2102871 · Received May 3, 2011

    Report

    Report Number
    9612164-2011-00352
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 4, 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). EVALUATION SUMMARY: THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATIONS. THE NINTH PROXIMAL SEGMENT WAS RAISED, DEFORMED AND PULLED DISTALLY. A PROTECTIVE SHEATH COULD NOT BE PLACED OVER THE STENT DUE TO THE RAISED STENT STRUTS. THE DAMAGED STENT SEGMENT OD EXCEEDED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.25 MM DIAMETER X 30 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE RCA. THE TARGET LESION HAD SOME CALCIFICATION. THE LESION WAS PRE-DILATED ONCE USING A 1.25 MM X 20 MM SPRINTER BALLOON AT 12 ATM'S. EIGHTY PERCENT STENOSIS REMAINED FOLLOWING PRE-DILATION. THE ENDEAVOR SPRINT DEVICE COULD NOT PASS THE LESION AND THE DEVICE WAS REMOVED. THE STRUTS OF THE STENT WERE NOTED TO BE DAMAGED. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. FURTHER PRE-DILATION OF THE LESION WAS THEN PERFORMED AND THE TARGET LESION WAS TREATED USING ANOTHER ENDEAVOR STENT OF THE SAME SIZE. PATIENT'S STATUS POST-PROCEDURE WAS 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 0002661776

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK