BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2013317 · Received March 10, 2011

    Report

    Report Number
    2024168-2011-01544
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, MYOCARDIAL INFARCTION, ISCHEMIA AND THROMBOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE, AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. 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 APPROXIMATELY TWENTY SIX MONTHS POST STENTING PROCEDURE WITH THREE XIENCE V STENTS, ONE 2.5 X 12 IN THE PROXIMAL CIRCUMFLEX ARTERY, ONE 3.0 X 12 IN THE MID LEFT ANTERIOR DESCENDING ARTERY AND ONE 3.0 X 15 IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, THE PATIENT EXPERIENCED CHEST DISCOMFORT AND WAS FOUND TO HAVE A POSITIVE FUNCTIONAL STRESS TEST DEMONSTRATING MYOCARDIAL ISCHEMIA. THE ANGIOGRAPHY STUDY SHOWED A THROMBOSIS OF THE INDEX STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION. ON 02/03/2011, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, INDEX TARGET LESION AND WAS TREATED WITH MEDICATIONS. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE. 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 9020461

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R| S STENT: XIENCE V 2.5X 12, XIENCE V 3.0 X 12