BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2040871 · Received March 24, 2011

    Report

    Report Number
    9612164-2011-00103
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    November 20, 2010
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: CVA. EVALUATION CONCLUSION: NO CONCLUSION CAN BE DRAWN. BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    PT HAD ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED DURING INDEX PROCEDURE. APPROX 4 YEARS 9 MONTHS POST INDEX PROCEDURE, THE PT WAS ADMITTED TO HOSP WITH LEFT PONTINE ISCHEMIC STROKE. MAGNETIC RESONANCE IMAGING OF THE BRAIN SHOWED LEFT PONS SUBACUTE INFARCT, OLD ISCHEMIC CHANGES INVOLVING THE RIGHT CEREBELLUM AND LEFT BASAL GANGLIA, AND MICROVASCULAR DISEASE. INTRACRANIAL MR ANGIOGRAPHY IDENTIFIED A SMALL ANEURYSM INVOLVING THE SUPRACLINOID LEFT INTERNAL CAROTID ARTERY 2 MM IN SIZE. EXTRACRANIAL MR ANGIOGRAPHY IDENTIFIED POSSIBLE STENOSIS OF THE ORIGIN OF THE LEFT VERTEBRAL ARTERY. TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED NORMAL LEFT VENTRICULAR FUNCTION WITH AN EJECTION FRACTION OF 85% AND NO CARDIAC SOURCE OF EMBOLI. PT WAS TREATED WITH MEDICATION AND DISCHARGED HOME APPROX 2 WEEKS LATER. IT IS REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE/ DRUG PROCEDURE.

    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 86 YR Hospitalization| L