BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1894914 · Received November 5, 2010

    Report

    Report Number
    2953200-2010-02161
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: TORTUOSITY, CALCIFICATION, STENOSIS; STENT DISLODGEMENT; GUIDELINER; NO DEVICE RECEIVED FOR EVAL. EVAL, CONCLUSIONS: TORTUOSITY, CALCIFICATION, STENOSIS.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN TO A PT. THE TARGET LESION, LOCATED IN THE PROXIMAL PORTION OF THE RCA, WAS DESCRIBED AS TORTUOUS AND CALCIFIED WITH 95% STENOSIS. PRIOR TO THIS, ONE OTHER ENDEAVOR SPRINT RX WAS SUCCESSFULLY DEPLOYED TO MID RCA. HOWEVER, IT WAS REPORTED THAT AS RESISTANCE WAS ENCOUNTERED ATTEMPTING TO ADVANCE THE RELEVANT DEVICE THROUGH THE GUIDELINER AND ACROSS THE LESION, SOME FORCE WAS APPLIED. IT WAS REPORTED THAT THE RELEVANT STENT DISLODGED AT THE OSTIUM OF THE RCA DURING ATTEMPTS BY THE PHYSICIAN TO WITHDRAW THE STENT AND DELIVERY SYSTEM BACK INTO THE GUIDELINER. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DISLODGED STENT USING A BALLOON AND 2 ADDITIONAL GUIDEWIRES; HOWEVER THE STENT MOVED DOWN TO THE PT GROIN AND REMAINED IN THE PT. IT WAS REPORTED THAT THE PT WAS SENT TO SURGERY AND HAD BYPASS. THE PT IS REPORTED TO BE FINE AND NO OTHER 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 0001165176

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention