BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904601 · Received November 22, 2010

    Report

    Report Number
    2024168-2010-02491
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    July 31, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    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 PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A BATTERY DEPLETED SET ALARM, WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE PREDILATED LEFT DISTAL CIRCUMFLEX ARTERY WITH ONE 2.5 X 23 XIENCE V STENT, IN THE PREDILATED LEFT FIRST OBTUSE MARGINAL (OM1) WITH ONE 3.0 X 12 XIENCE V STENT, AND IN THE PREDILATED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH TWO XIENCE V STENTS SIZES 3.0 X 28 AND 3.0 X 15. ON 7/31/2010 THE PATIENT EXPERIENCED CHEST PRESSURE, DIAPHORESIS, AND CHEST TIGHTNESS CLASSIFIED AS UNSTABLE ANGINA. THE PATIENT UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY ON (B)(6) 2010 THAT FOUND 30 TO 40% STENOSIS IN THE DISTAL LAD AND 30% IN-STENT RESTENOSIS IN THE OM1. THERE WAS NO REVASCULARIZATION PERFORMED. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. 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 8010761

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| S