BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2251342 · Received September 13, 2011

    Report

    Report Number
    9612164-2011-01138
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    March 26, 2012
    Report Date
    March 27, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: GI BLEED.

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING DURING THE INDEX PROCEDURE. AT 30 DAY FOLLOW UP PATIENTS WORST ANGINA STATUS WAS REPORTED AS II PER (B)(6) OF ANGINA. IT IS REPORTED THAT THE PT WAS TREATED WITH MEDS FOR BRONCHITIS APPROXIMATELY 5.5 MONTHS POST INDEX PROCEDURE. AT 6 MONTH FOLLOW UP PATIENTS WORST ANGINA STATUS WAS REPORTED AS I PER THE CCSC OF ANGINA. THE PT PRESENTED WITH HIVES APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE WITH A REMOTE RELATION TO ANTIPLATELET STUDY DRUG. APPROXIMATELY 8.5 MONTHS POST INDEX PROCEDURE THE PT WAS TREATED FOR INFECTIOUS (B)(6). CT SHOWED COLONIC THICKENING SECONDARY TO INFECTIOUS ORIGIN. THERE WAS ALSO BLOOD IN STOOL. PT WAS TREATED WITH ANTIBIOTICS, PAIN MEDS AND ASACOL. IT IS REPORTED THAT THE PT SUFFERED A SPONTANEOUS GI BLEED WHICH RESULTED IN EXTENDED HOSPITALIZATION. THE PT WAS TAKING ASPIRIN AND CLOPIDOGREL 24 HOURS BEFORE THE EVENT. IN THE SAME TIME FRAME THE PT WAS TREATED FOR (B)(6), PRESENTING WITH HYPOTENSION AND BRADYCARDIA, TREATED WITH IV ANTIBIOTICS, CROHNS DISEASE EGD AND HISTOPATHOLOGY COMPLETED. IT IS ALSO REPORTED THAT THE PT DEVELOPED SICK SINUS SYNDROME WHICH WAS TREATED WITH BETA BLOCKERS UNTIL A PERMANENT PACEMAKER (PPM) INSERTION WAS DONE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A SPONTANEOUS GI BLEED APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE. THE INVESTIGATOR HAS INDICATED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT IS CONTINUING WITH TREATMENT.

    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 52 YR Hospitalization CLOPIDOGREL| ASPIRIN