BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1983017 · Received February 7, 2011

    Report

    Report Number
    2953200-2011-00297
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    December 3, 2013
    Report Date
    December 12, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSION: HAEMORRHAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    CONTINUED FROM CONCOMITANT MEDICAL PRODUCTS: LIPID LOWERING DRUGS. (B)(4): DISSECTION. PATIENT'S AGE AT TIME OF EVENT WAS (B)(6) NOT (B)(6) AS REPORTED IN INITIAL REPORT.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD 2 ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS IMPLANTED TO THE MID LAD. DURING IMPLANTATION A DISSECTION OCCURRED. IT IS UNKNOWN HOW THE DISSECTION WAS TREATED. (REF MFR # 9612164-2012-00026)

    Description of Event or Problem · 1

    APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED DUE TO A GI BLEED. THE PATIENT WAS TREATED WITH MEDICATION AND A TRANSFUSION. ANTIPLATELET MEDICATION WAS STOPPED DUE TO THE EVENT AND RESUMED 4 DAYS POST THE GI BLEED. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE IT IS REPORTED THAT THE ISSUE IS NOT RESOLVED.

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT WAS DEPLOYED IN THE MID LAD OF A PATIENT WITH NO ISSUES REPORTED. IT WAS REPORTED THAT THE PATIENT HAD AN MI ONE DAY POST IMPLANT OF THE RELEVANT STENT. PROLONGED HOSPITALIZATION WAS REQUIRED. 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 0001031882

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization OMEPRAZOL| DAPT| ASA| BETA, ANGIOTENSIN, CA++ ANTAGONIST| CLOPIDOGREL