BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2231140 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01040
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 31, 2011
    Report Date
    July 31, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: ROOT CAUSE OF EVENT CANNOT BE DETERMINED. THROMBOSIS. NO DEVICE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO TREAT A LESION TO THE PROXIMAL LEFT ARTERY DESCENDING TO TREAT RESTENOSIS OF A NON-MEDTRONIC STENT. THE PHYSICIAN IMPLANTED A 2.5 X 24 ENDEAVOR SPRINT STENT SUCCESSFULLY. SEVERAL HRS POST PROCEDURE PT COMPLAINED OF CHEST PAIN AND A CHANGE ON THE ELECTROCARDIOGRAM WAS OBSERVED. THE THROMBOSIS WAS ASPIRATED AND LESION WAS DILATED WITH A HIGH PRESSURE BALLOON. THE PHYSICIAN NOTED THAT THE THROMBUS MAY HAVE MIGRATED FROM THE INSIDE OF A NON MEDTRONIC DEVICE. THERE WAS NO PT INJURY REPORTED AND THE PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0004999342

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CLOPIDOGREL| ASPIRIN