BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1744456 · Received June 30, 2010

    Report

    Report Number
    2953200-2010-01229
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    August 11, 2009
    Report Date
    May 31, 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, REVASCULARIZATION. SUNG SOO KIM ET AL. "SEQUENTIAL DEVELOPMENT OF CARDIAC TAMPONADE AND SUBACUTE STENT THROMBOSIS AFTER PRIMARY PERCUTANEOUS CORONARY INTERVENTION FOR ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: A CASE REPORT" JOURNAL OF CARDIOLOGY CASES (2010) 1, E75-E79.

    Description of Event or Problem · 1

    A PT UNDERWENT SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). BALLOON ANGIOPLASTY WAS PERFORMED FOLLOWED BY DEPLOYMENT OF AN ENDEAVOR RX DRUG-ELUTING STENT. RESIDUAL THROMBOSIS REMAINED AND ADDITIONAL BALLOON DILATION WAS PERFORMED. FINAL CAG SHOWED THROMBOLYSIS IN MYOCARDIAL INFARCTION III ANTEGRADE FLOW BUT RESIDUAL STENOSIS DISTAL TO THE STENT. FIVE HOURS POST INDEX PROCEDURE PT DEVELOPED COLD SWEATING AND WENT INTO A STUPOR. A REPEAT EMERGENT ANGIOGRAPHY (CAG) WAS DONE. THE CAG SHOWED A PATENT STENT IN THE MIDDLE LAD. EMERGENT PERICARDIOCENTESIS WAS PERFORMED AND PT'S BLOOD PRESSURE RETURNED TO NORMAL. SEVEN DAYS LATER, THE PT PRESENTED TO THE EMERGENCY DEPT WITH CONTINUOUS CHEST PAIN. EMERGENT CAG SHOWED TOTAL OCCLUSION OF THE LAD DUE TO SUBACUTE STENT THROMBOSIS. THE PT WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY. AT 9 MONTH FOLLOW-UP, CAG SHOWED A GOOD FLOW WITHOUT RESIDUAL STENOSIS ACROSS THE STENTED SEGMENT. NO CLINICAL SEQUELAE WERE REPORTED. REVIEW OF ANGIOGRAM IMAGES: CHRONIC TOTAL OCCLUSION (CTO) OF THE LAD HAS BEEN IDENTIFIED IN THE IMAGES PROVIDED.

    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 42 YR Required Intervention