BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1850898 · Received September 29, 2010

    Report

    Report Number
    2953200-2010-01859
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 17, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON INFO AVAILABLE, DISSECTION.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT (DETAILS UNK) WAS DEPLOYED IN TO A PT. THE TARGET LESION, LOCATED IN THE PROXIMAL AND MID LAD WAS DESCRIBED AS A COMPLEX LESION WHICH WAS ALSO INVOLVING THE FIRST DIAGONAL BRANCH OF THE LAD. HOWEVER, IT WAS REPORTED THAT AFTER THE DEPLOYMENT OF THIS STENT DISSECTION WAS CONFIRMED AT THE DISTAL EDGE OF THE STENT. TO TREAT THE DISSECTION, AN ATTEMPT WAS MADE TO PLACE A SECOND ENDEAVOR STENT DISTAL THE FIRST STENT. HOWEVER, IT WAS REPORTED THAT THIS STENT WOULD ONLY PASS 1 OR 2 MM INTO THE ORIGIN OF THE DIAGONAL ARTERY AND ON REMOVAL FROM THE PT IT DISLODGED IN VIVO (MFR # 2953200-2010-01858). THE PHYSICIAN WAS ABLE TO INSERT A BALLOON AND DEPLOY THE DISLODGED STENT IN THE VASCULATURE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention