BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1253521 · Received December 5, 2008

    Report

    Report Number
    2024168-2008-01278
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    July 22, 2008
    Report Date
    November 3, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. RESTENOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. 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, THE RESTENOSIS WAS TREATED WITH ANOTHER DRUG ELUTING STENT. THEREFORE, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT ISSUE AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS, REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT DURING THE INDEX PROCEDURE, A 2.5 X 18 MM XIENCE V STENT WAS DEPLOYED IN THE MID LEFT ARTERIOR DESCENDING ARTERY (LAD) IN 2008. THREE MONTHS LATER, THE PT RETURNED AND THE MID (LAD) WAS FOUND TO HAVE RESTENOSIS. REVASCULARIZATION WAS PERFORMED AND ANOTHER COMPANY'S DRUG ELUTING STENT WAS DEPLOYED TO TREAT THE RESTENOSIS. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 71129P8

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R