BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1964298 · Received January 19, 2011

    Report

    Report Number
    2024168-2011-00380
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    April 28, 2010
    Report Date
    December 25, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE 3.5 X 15 MM XIENCE V (1009542-15, 7110641) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ABOVE RATED BURST PRESSURE, INDICATION FOR USE. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, MYOCARDIAL INFARCTION, AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED IN A 30 MM LONG LESION, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESION LENGTHS GREATER THAN 28MM. IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY TWENTY MONTHS POST XIENCE V STENT IMPLANTATION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH TWO XIENCE V STENTS, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN. ECG RESULTS SHOWED NON-ST ELEVATION MYOCARDIAL INFARCTION. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION FOR MILD IN-STENT RESTENOSIS IN THE MID RIGHT CORONARY ARTERY. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. ALTHOUGH REQUESTED, 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 8051761

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R| S STENT: 3.5 X 15 MM XIENCE V ((B)(4))