BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2160595 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00689
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    October 9, 2010
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS AND CONCLUSION: (COMORBIDITIES), (RESTENOSIS, MI).

    Description of Event or Problem · 1

    TWO ENDEAVOR RAPID EXCHANGE DRUG ELUTING STENTS WERE SUCCESSFULLY IMPLANTED OVERLAPPING IN THE MID LAD. APPROX 9 MONTHS POST INDEX PROCEDURE THE PT VISITED THE HOSP COMPLAINING OF CHEST PAIN. AN ECG CHECK CONFIRMED AN MI. IN STENT RESTENOSIS WAS FOUND AT THE MID LAD AND SEVERE STENOSIS AT THE 1ST DIAGONAL. TWO NON-MEDTRONIC STENTS WERE PLACED IN THE MID LAD AND THE 1ST DIAGONAL TO TREAT THIS RESTENOSIS. THE INVESTIGATOR REPORTS THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE PROCEDURE OR ZOTAROLIMUS BUT THERE WAS A RELATIONSHIP WITH THE PRODUCT. PT IS REPORTED TO BE IN REMISSION. NO ADD'L CLINICAL SEQUELAE WERE REPORTED. REFERENCE MFR REPORT NUMBER 9612164201100688.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R CLOPIDOGREL| ASPIRIN