BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1902294 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02418
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 17, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OTHER XIENCE V (1009541-18, 9051443) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. EVAL SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, MYOCARDIAL INFARCTION (MI) AND RE-STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS. IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED WITH NO PRE-DILATATION. IT SHOULD BE NOTED THAT 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 10 MONTHS POSTS TO 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 MFG, DESIGN OR LABELING 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 APPROX 10 MONTHS POST XIENCE V STENT IMPLANTATION IN A RESTENOSED MID RIGHT CORONARY ARTERY (MRCA) AND DIRECT STENTING TO A DE NOVO PROXIMAL CIRCUMFLEX ARTERY (PCX), THE PT EXPERIENCED ANGINA WHICH RESOLVED WITH MEDICATION. ON (B)(6) 2010, THE PT WAS DIAGNOSED WITH A NON-ST ELEVATION MYOCARDIAL INFARCTION (NONSTEMI) AND WAS TAKEN TO THE CATHETER LAB WHERE 95% IN-STENT RESTENOSIS (ISR) WAS FOUND IN THE MRCA AND 90% OSTIAL ISR WAS FOUND IN THE PCX. CUTTING BALLOON PROCEDURE WAS PERFORMED. ON (B)(6) 2010, THE PT WAS DISCHARGED TO HOME. ALTHOUGH 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 9012861

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R XIENCE V (1009541-18, 9051443)| STENT: TAXUS STENT