BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2031202 · Received March 22, 2011

    Report

    Report Number
    9612164-2011-00099
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    May 11, 2010
    Report Date
    February 21, 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) - RESULTS: NO CONCLUSION CAN BE DRAWN. DEVICE/CINE IMAGES NOT AVAILABLE, OCCLUSION. BASED ON THE INFORMATION PROVIDED NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RX DRUG ELUTING STENT DIAMETER 2.5 MM LENGTH 12 MM WAS DEPLOYED TO THE PROXIMAL CIRCUMFLEX AND THE 1ST OBTUSE MARGINAL DURING INDEX PROCEDURE. CHEST PAIN REMAINED AFTER PCI. AN OCCLUSION OF A SIDE BRANCH POST DEPLOYMENT OF THE STENT WAS REPORTED CAUSING SLOW BLOOD FLOW, POSSIBLY DUE TO THE PRESENCE OF STENT MATERIAL ACROSS THE OSTIUM OF THE SIDE BRANCH. SYMPTOMS DISAPPEARED 3 DAYS POST INDEX PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization