BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 3860925 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00611
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 26, 2013
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (ROOT CAUSE UNDETERMINED DEVICE/IMAGES NOT RETURNED). INHERENT RISK OF PROCEDURE (STENT THROMBOSIS). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NONE (DEVICE NOT RETURNED FOR EVALUATION). CONCLUSION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT THROMBOSIS). UNABLE TO CONFIRM COMPLAINT (DEVICE NOT RETURNED). (ROOT CAUSE UNDETERMINED DEVICE/IMAGES NOT RETURNED). TITLE OF ARTICLE: THREE YEAR CLINICAL OUTCOMES WITH ZOTAROLIMUS (ENDEAVOR) DRUG-ELUTING STENTS IN AN UNRESTRICTED CONTEMPORARY PRACTICE. HTTP://DX.DOI.ORG/10.1016/J.IJCARD.2013.01.234.

    Description of Event or Problem · 1

    PATIENTS RECEIVING ENDEAVOR STENTS BETWEEN (B)(6) 2005 AND (B)(6) 2007 WERE INCLUDED FOR ANALYSIS. IN TOTAL WE IDENTIFIED 494 PATIENTS WITH 625 LESIONS TREATED WITH 717 ZESS. THIS COHORT INCLUDED A LARGE PERCENTAGE OF HIGH-RISK PATIENTS, INCLUDING PATIENTS WITH DIABETES 31.2%), TARGET LESIONS IN VESSELS LESS THAN 3.0 MM(47.5%), LESIONS GREATER THAN 20 MIN LENGTH (45.5%) AND PATIENTS BEING TREATED FOR ACS (66.2%). ADDITIONALLY, A LARGE NUMBER OF PATIENTS WITH PRIOR PCI (25.3%) AND BYPASS SURGERY (10.3%) WERE REPRESENTED IN THE COHORT. INTERESTINGLY, DESPITE THE PREVALENCE OF HIGH-RISK PATIENTS, THE CUMULATIVE RATES OF CARDIAC DEATHS (4.5%), MIS (6.8%), AND ST (0.9%) WERE EXCEEDINGLY LOW AT 36 MONTHS. THREE CASES OF ARC DEFINITE STENT THROMBOSIS OCCURRED DURING THE STUDY PERIOD, WHICH OCCURRED IN THE FIRST 12 MONTHS. THE 36-MONTH CUMULATIVE RATE FOR TVR WAS 12.2% IN THE STUDY ONLY FOUR PATIENTS EXPERIENCED ARC DEFINITE/PROBABLE ST AND ALL EVENTS OCCURRED WITHIN THE FIRST 12 MONTHS (0.9%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342158 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR