BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231849 · Received November 12, 2008

    Report

    Report Number
    2024168-2008-01130
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. THROMBOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE AND PRODUCT RISK ASSESSMENT, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. AS THERE WAS NO REPORTED DEVICE MALFUNCTION AT THE TIME OF THE PROCEDURE, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A STENT DELIVERY SYSTEM QUALITY PROBLEM. IN THIS CASE, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT ISSUE OF THROMBOSIS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: THROMBOSIS. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD). THE PT CAME BACK TWO DAYS LATER WITH SUB ACUTE THROMBOSIS. THE PT WAS ON PLAVIX. THE PT'S CONDITION IS UNK. NO ADD'L EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability