BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2201844 · Received August 5, 2011

    Report

    Report Number
    9612164-2011-00881
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: RESULTS: COMPLEX NATURE OF THE TARGET LESION; DISSECTION. EVAL: CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (COMPLEX NATURE OF THE TARGET LESION).

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN LCX OF A PT. IT WAS REPORTED THAT A MINOR HEMODYNAMIC DISSECTION WAS OBSERVED AFTER MULTIPLE BALLOON PRE-DILATIONS AND DEPLOYMENT OF THE ENDEAVOR SPRINT STENT. THE VESSEL WAS REPORTED TO BE EXCESSIVELY TORTUOUS, WITH 80% STENOSIS AND MODERATELY CALCIFIED PRIOR TO THE STENT DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention