BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1973390 · Received January 30, 2011

    Report

    Report Number
    2024168-2011-00552
    Event Type
    Injury
    Date Received
    January 30, 2011
    Date of Event
    December 1, 2008
    Report Date
    January 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINED IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THIS WAS AN ADDITIONAL LESION, WHICH WAS ALREADY PRESENT AT THE TIME OF THE INDEX PROCEDURE. HOWEVER, IT WAS UNDERESTIMATED AND IT WAS DECIDED NOT TO TREAT IT AT THE TIME. DURING ONE YEAR FOLLOW UP, IT WAS DECIDED THAT THE ADDITIONAL LESION NEEDED TREATMENT AND A BYPASS WAS PERFORMED. THIS WAS CONFIRMED TO BE AN ADDITIONAL LESION AND NOT RESTENOSIS OF THE LESION TREATED DURING THE INDEX PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT "PRE-STENT STENOSIS" OCCURRED IN THE MID LEFT ANTERIOR DESCENDING (LAD) SIX MONTHS POST STENT PLACEMENT. REPORTEDLY, IT WAS NOT A RESTENOSIS. DURING THE PROCEDURE THE LESION HAD BEEN IDENTIFIED, BUT IT WAS "UNDERESTIMATED". THEREFORE, ONE YEAR LATER IT WAS OPPORTUNE TO PERFORM A CORONARY ARTERY BYPASS GRAFT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR FILING, ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THIS WAS AN ADDITIONAL LESION, ALREADY PRESENT AT THE TIME OF THE INDEX PROCEDURE BUT IT WAS UNDERESTIMATED AND IT WAS DECIDED NOT TO TREAT IT AT THE TIME. DURING ONE YEAR FOLLOW UP, IT WAS DECIDED THAT THE ADDITIONAL LESION NEEDED TREATMENT AND A BYPASS WAS PERFORMED. THIS WAS CONFIRMED TO BE AN ADDITIONAL LESION AND NOT RESTENOSIS OF THE LESION TREATED DURING THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R