BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1963851 · Received December 22, 2010

    Report

    Report Number
    2953200-2010-02614
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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: EXCESSIVE TORTUOSITY, MODERATE CALCIFICATION. FAILURE TO DELIVER THE STENT, STENT DEFORMATION. EVAL CONCLUSIONS: EXCESSIVE TORTUOSITY, MODERATE CALCIFICATION. DEVICE AND CINE IMAGE EVAL: THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECS. A NUMBER OF STENT SEGMENTS WERE MISALIGNED AND SLIGHTLY RAISED. THE DISTAL TIP APPEARED SLIGHTLY PINCHED AND FLATTENED. REVIEW OF THE CINE IMAGES CONFIRMED THE EXCESSIVE TORTUOSITY PRESENT IN THE VESSEL.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75 MM DIAMETER X 30 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IN A PT. THE LESION WAS PRE-DILATED TWICE WITH A 2.5 MM X 15 MM BALLOON. THE TARGET VESSEL WAS REPORTED TO EXHIBIT EXCESSIVE TORTUOSITY AND MODERATE CALCIFICATION AT THE LESION SITE. THE ENDEAVOR SPRINT STENT FAILED TO REACH THE TARGET LESION AND WAS REMOVED FROM THE PT. 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 CARDIOVASCULAR GALWAY NA 0002877107

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK