BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242211 · Received November 19, 2008

    Report

    Report Number
    2024168-2008-01181
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 31, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION AND OCCLUSION ARE KNOWN OUTCOMES OF CORONARY STENTING PROCEDURES, AND ARE LISTED IN THE DEVICE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS. THERE WERE NO REPORTS OF DIFFICULTIES DEPLOYING THE STENT OR DAMAGE TO THE SDS WHICH COULD HAVE CONTRIBUTED TO EITHER PATIENT EFFECT. IT IS POSSIBLE THAT THE OCCLUSION WAS RELATED TO THE POSITIONING OF THE STENT IMPLANT, THOUGH THIS COULD NOT BE CONFIRMED. A DEFINITE ROOT CAUSE FOR THE PATIENT EFFECTS REPORTED AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. THERE ARE NO INDICATIONS OF PRODUCT QUALITY ISSUES CONTRIBUTING TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - PERMANENT DAMAGE. REPORTING RATIONALE: JAILING OF THE STENT CAUSING OCCLUSION/PERMANENT DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT THERE WAS A VERY SMALL NON FLOW LIMITING DISSECTION AT THE DISTAL EDGE OF THE LOWER STENT DURING A PROCEDURE WITH THE RX XIENCE V. REPORTEDLY, NO TREATMENT WAS PERFORMED. NO DEVICE ISSUE WAS REPORTED. THERE WAS ALSO JAILING OF A SMALL SEPTAL BRANCH AND THERE WAS NO TREATMENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8061161

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability