BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901995 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02435
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 22, 2010
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RE-STENOSIS IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. IT WAS REPORTED THAT THE XIENCE V STENT WAS DIRECT STENTED (IMPLANTED WITH NO PRE-DILATATION). THE IFU STATES TO PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. LIMIT THE LONGITUDINAL LENGTH OF PRE-DILATATION BY THE PTCA BALLOON TO AVOID CREATING A REGION OF VESSEL INJURY THAT IS OUTSIDE THE BOUNDARIES OF THE XIENCE V STENT. THE DIRECT STENTING (NO PRE-DILATATION) DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED PT EFFECTS AS THE PT EFFECTS WERE REPORTED 2 YEARS POSTS TO THE PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING OR DESIGN AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROXIMATELY 2 YEARS POST DIRECT STENTING OF A XIENCE V OTW STENT INTO THE MID CIRCUMFLEX ARTERY (MCX), THE PT HAD A POSITIVE EXERCISE STRESS TEST AND WAS FOUND TO HAVE 70% IN-STENT STENOSIS. A NON-ABBOTT DRUG ELUTING STENT WAS PLACED WITHIN THE XIENCE STENT. THERE WAS NO ADVERSE PT SEQUELA REPORTED. ON (B)(6) 2010, THE PT WAS DISCHARGED TO HOME. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    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 8060661

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R ASPIRIN| OTHER: CLOPIDOGREL| STENT: XIENCE V OTW, 1009545-12, LOT# 8062361