BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1782697 · Received July 28, 2010

    Report

    Report Number
    2953200-2010-01423
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 30, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS - (STENT THROMBOSIS/OCCLUSION), (DIABETES MELLITUS). CONCLUSION: (DIABETES MELLITUS). KOREAN CIRC J 2010; 40:243-246: THE KOREAN SOCIETY OF CARDIOLOGY; SIMULTANEOUS MULTI-VESSEL SUBACUTE STENT. THROMBOSES IN ZOTAROLIMUS-ELUTING STENTS.

    Description of Event or Problem · 1

    THE PT PRESENTED AT THE EMERGENCY ROOM WITH CHEST PAIN. CRITICAL STENOSIS AT THE PROXIMAL SEGMENT OF THE RIGHT CORONARY ARTERY (RCA) WAS NOTED ALONG WITH SEVERE STENOSIS IN THE PROXIMAL SEGMENT OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). ONE ENDEAVOR RX 2.75 DIAMETER X 30 LENGTH (REF MFR# 2953200-2010-01422) WAS IMPLANTED TO THE RCA AND ONE ENDEAVOR RX 2.75MM DIAMETER X 14MM LENGTH WAS IMPLANTED TO THE LAD. ASPIRIN AND CLOPIDOGREL WERE ADMINISTERED DAILY AFTER STENT IMPLANTATION. SIX DAYS POST IMPLANT, SUDDEN VENTRICULAR TACHYCARDIA FOLLOWED BY VENTRICULAR FIBRILLATION DEVELOPED ALONG WITH CHEST PAIN AND DYSPNEA OCCURRED. CORONARY ANGIOGRAPHY SHOWED TOTAL OCCLUSION OF THE PREVIOUSLY IMPLANTED STENTS AT BOTH PROXIMAL LAD AND RCA. REVASCULARIZATION OF BOTH LESIONS WAS PERFORMED. PT WAS THEN PRESCRIBED CILOSTAZOL ALONG WITH ASPIRIN AND CLOPIDOGREL. PT WAS DISCHARGED 2 MONTHS LATER DUE TO RENAL FAILURE AND HAS NOT EXPERIENCED ANY FURTHER ISCHEMIC EVENTS. REVIEW OF IMAGES: REVIEW OF THE IMAGES CONTAINED IN THE JOURNAL ARTICLE CONFIRM THE OCCURRENCE OF A TOTAL OCCLUSION OF THE ENDEAVOR STENTS IMPLANTED IN THE RCA AND LAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention CLOPIDOGREL WERE ADMINISTERED BEFORE EMERGENCY| ASPIRIN| CORONARY ANGIOGRAPHY.