BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1933204 · Received December 20, 2010

    Report

    Report Number
    2024168-2010-02826
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    May 14, 2010
    Report Date
    November 25, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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. (B)(4) - NO PRE-DILATATION THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. REPORTEDLY, THE XIENCE V STENT WAS DIRECT STENTED (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. THE DIRECT STENTING DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS AS THE PATIENT EFFECTS WERE REPORTED APPROXIMATELY 2 YEARS AFTER THE INITIAL PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT DIRECT STENTING IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH ONE 3.5 X 8 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED ARM PAIN SIMILAR TO ANGINA AND WAS FOUND TO HAVE 80% IN-STENT RESTENOSIS IN THE OSTIAL LAD. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION WITH CUTTING BALLOON ANGIOPLASTY. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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 7121061

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R