BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1678637 · Received May 7, 2010

    Report

    Report Number
    2953200-2010-00791
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    September 22, 2009
    Report Date
    November 15, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION, RESULTS: DISSECTION, STENT THROMBOSIS, TVR, GI BLEED.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED TO THE DISTAL LAD. AN ENDEAVOR SPRINT STENT WAS IMPLANTED TO THE PROXIMAL LAD. A SECOND ENDEAVOR SPRINT STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT TO TREAT A DISSECTION BAILOUT IN THE PROXIMAL LAD. (MFR REPORT# 2953200-2010-00790, 2953200-2010-00792) THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT THE 30 DAY FOLLOW UP, THE PATIENT HAD STABLE ANGINA. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD INSTENT RESTENOSIS AND SUSPECTED STENT THROMBOSIS. TVR WAS PERFORMED TO THE PROXIMAL LAD. THE INVESTIGATOR STATED THAT THERE WAS A DEFINITE RELATIONSHIP TO THE STUDY DEVICE AND NO RELATIONSHIP TO THE PROCEDURE. APPROXIMATELY 5 1/2 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO A GASTROINTESTINAL BLEED. THE PATIENT HAD 2 DAY RECTAL BLEEDING, MEDICATION WAS ADMINISTERED AND A COLONOSCOPY WAS PERFORMED. THE PATIENT RECOVERED WITH TREATMENT. THE INVESTIGATOR STATED THAT THERE WAS NO RELATIONSHIP OF THE GASTROINTESTINAL BLEED AND THE STUDY STENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention UNK.