BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1935449 · Received November 10, 2010

    Report

    Report Number
    2953200-2010-02177
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 26, 2010
    Report Date
    October 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: (SEVERELY TORTUOUS VESSEL), (PREVIOUSLY DEPLOYED STENT), (STENT DEFORMATION AND FAILURE TO DELIVER STENT). CONCLUSION: PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY TORTUOUS VESSEL), (HITTING THE ORIGIN OF PREVIOUSLY DEPLOYED STENT).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT DELIVERY SYS LENGTH 18MM, DIAMETER 2.5MM WAS USED TO TREAT A SIGNIFICANTLY TORTUOUS LESION IN A PT'S CIRCUMFLEX. IT HAS BEEN CONFIRMED THAT THE TORTUOUS NATURE OF THE LCX COMBINED WITH A PREVIOUSLY DEPLOYED STENT IN THE LAD CLOSE TO THE OSTIUM OF THE LCX IMPACTED ON THE DELIVERY OF THE STENT. THE PHYSICIAN REPORTED DEFORMATION OF THE PROXIMAL STENT STRUTS DURING ATTEMPTED ADVANCEMENT AND THE STENT WAS WITHDRAWN. THE LESION WAS SUCCESSFULLY TREATED USING A SHORTER ENDEAVOR STENT. THE PT WAS REPORTED TO BE FINE POST PROCEDURE AND NO CLINICAL SEQUELAE HAVE BEEN 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 60 YR