BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2040865 · Received March 24, 2011

    Report

    Report Number
    9612164-2011-00110
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: GI BLEED. 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 TWO ENDEAVOR SPRINT RX DRUG ELUTING STENTS IMPLANTED TO THE PROXIMAL RCA. APPROX 3 WEEKS POST INDEX PROCEDURE, THE PT SUFFERED A GI BLEED. THE FOLLOWING WAS REPORTED: H/O APICAL THROMBUS ON COUMADIN FOR 3 MONTHS ONLY. C/O WEAKNESS, TARRY STOOLS HG 8.3, INR 1.7 ADMITTED TO HOSP. S/P COLON-NO BLEED, S/P UGI-BLEEDING AT DUODENUM. TWO UNITS OF PRBC, PLAVIX HELD X 2. DC HOME STABLE. PT WAS HOSPITALIZED FOR 6 DAYS AND TREATED WITH A PRBC TRANSFUSION. PT WAS ALSO REPORTED TO HAVE UNDERGONE A POLYPECTOMY DURING HOSPITALIZATION. THE INVESTIGATOR REPORTS THAT THE GI BLEED WAS NOT RELATED TO THE STUDY STENT/ PROCEDURE, BUT WAS PROBABLY RELATED TO THE ANTIPLATELET STUDY DRUG. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT. (REF MFR #9612164-2011-00109).

    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 67 YR Hospitalization| R AND PRASUGREL AT TIME OF EVENT| CLOPIDOGREL| PATIENT WAS ON ASPIRIN