BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RAPID EXCHANGE CORONARY STENT SYSTEM

    MDR report key: 2003527 · Received February 22, 2011

    Report

    Report Number
    2953200-2011-00464
    Event Type
    Death
    Date Received
    February 22, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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: NO DEVICE RETURNED FOR EVAL. (CO-MORBIDITIES). (GI BLEED, DEATH). (UNABLE TO FOLLOW UP).

    Additional Manufacturer Narrative · 1

    DAPT WAS DISCONTINUED FOLLOWING THE PREVIOUSLY REPORTED GI BLEED.

    Description of Event or Problem · 1

    AN ENDEAVOR RAPID EXCHANGE DRUG ELUTING STENT WAS IMPLANTED TO THE PROXIMAL RIGHT CORONARY ARTERY DURING INDEX PROCEDURE. ANOTHER NON-MEDTRONIC DRUG ELUTING STENT WAS ALSO IMPLANTED TO THE MID RIGHT CORONARY ARTERY. APPROXIMATELY 11 MONTHS LATER, THE PT WAS ADMITTED TO HOSPITAL DUE TO HEMATEMESIS. ENDOSCOPIC VARICEAL LIGATION WAS PERFORMED BECAUSE OF RUPTURE OF AN ESOPHAGEAL VARIX. APPROXIMATELY 1 YEAR POST INDEX PROCEDURE, THE PT WAS CONFIRMED DEAD FOLLOWING A CARDIOPULMONARY ARREST. PROCEDURAL IMAGES OR PRODUCT IDENTIFICATION HAVE NOT BEEN PROVIDED FOR REVIEW. IT IS REPORTED THAT THE CAUSE OF DEATH WAS THE ESOPHAGEAL VARIX. IT IS REPORTED THAT THERE WAS NO CAUSAL RELATIONSHIP WITH THE PRODUCT, THE DRUG OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RAPID EXCHANGE CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| R CLOPIDOGREL PRIOR TO EVENT