BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2141083 · Received June 21, 2011

    Report

    Report Number
    9612164-2011-00605
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULT AND CONCLUSION: (GI BLEED).

    Description of Event or Problem · 1

    APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED DUE TO UNSTABLE ANGINA. PATIENT WAS DIAGNOSED WITH A NON Q-WAVE MI. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE MI EVENT AND THE STUDY DEVICE, THE STUDY DRUG OR THE STUDY PROCEDURE. THE FOLLOWING DAY THE PATIENT UNDERWENT A TARGET VESSEL REVASCULARIZATION. THE PATIENT HAD ANOTHER STENT PLACED IN THE TARGET LESION AND A STENT PLACED IN A NEW LESION.

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD DURING INDEX PROCEDURE. APPROXIMATELY 18 WEEKS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO HOSPITAL FOR A GI BLEED. PATIENT WAS TREATED WITH 4 UNITS OF PRBC TRANSFUSION AND IV PROTONIX. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY DEVICE. CLOPIDOGREL AND ASPIRIN WERE DISCONTINUED FOR 3 WEEKS. PATIENT IS REPORTED TO BE RECOVERING WITH TREATMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    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 64 YR Male Hospitalization| R ASPIRIN| CLOPIDOGREL| CLOPIDOGREL| ASPIRIN