BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT OTW

    MDR report key: 1921767 · Received December 8, 2010

    Report

    Report Number
    2953200-2010-02464
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: SEVERE CALCIFICATION, 80% STENOSIS; FORCE APPLIED TO THE DEVICE DURING ITS ADVANCEMENT; FAILURE TO DELIVER THE STENT, STENT DISLODGEMENT. EVAL CONCLUSION: CALCIFIED LESION, 80% STENOSIS; FORCE APPLIED TO THE DEVICE DURING ITS ADVANCEMENT.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 2.5 MM DIAMETER X 30 MM LENGTH ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG ELUTING CORONARY STENT IN TO A PT. THE TARGET LESION, LOCATED IN THE CIRCUMFLEX WAS DESCRIBED AS VERY CALCIFIED AND STILL EXHIBITING 80% STENOSIS AFTER PREDILATATION. IT WAS REPORTED THAT THE CASE WAS EXTREMELY DIFFICULT WITH MANY OTHER DEVICES USED UNSUCCESSFULLY (DEVICES DETAILS UNK). IT WAS REPORTED THAT AS RESISTANCE WAS ENCOUNTERED, FORCE WAS APPLIED TO THE DEVICE DURING ITS ADVANCEMENT AND ON WITHDRAWAL, THE STENT DISLODGED FROM THE BALLOON BECOMING STUCK INSIDE THE GUIDE CATHETER. THE GUIDE CATHETER WAS CUT OPEN AND THE STENT WAS NOTED TO BE STRETCHED AND DAMAGED. IT WAS REPORTED THAT THE CASE WAS COMPLETED WITH NO FURTHER ACTION AS DEEMED TO BE TOO DIFFICULT. NO HEALTH HAZARD WAS CAUSED TO THE PT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK