BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1972376 · Received January 25, 2011

    Report

    Report Number
    2953200-2011-00174
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    September 14, 2012
    Report Date
    February 27, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DISSECTION.

    Description of Event or Problem · 1

    ASA WAS WITHHELD AS A RESULT OF THE BLEED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PREVIOUSLY REPORTED DISSECTION WAS TREATED WITH AN ENDEAVOR SPRINT RX STENT TO THE LAD. IT IS REPORTED THAT APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A GI BLEED. THE PATIENT WAS TREATED WITH MEDICATION, A COLONOSCOPY AND A BLOOD TRANSFUSION. THE PATIENT WAS ON DAPT. IT HAS BEEN ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE AND THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID RCA DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT A CORONARY ARTERY DISSECTION OCCURRED DURING THE PROCEDURE WHICH REQUIRED INTERVENTION (REVASCULARIZATION). THE DISSECTION EVENT WAS CLASSIFIED AS MILD IN INTENSITY. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR THE STUDY DRUG. THE PT RECOVERED WITH TREATMENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0004336167

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R RAMIPRIL| ASPIRIN| ASPIRIN, CLOPIDOGREL AND PLAVIX| CLOPIDOGREL| METOPROLOL| OMEPRAZOLE