BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132931 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04332
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 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 PATIENT EFFECTS OF ANGINA, ISCHEMIA AND RESTENOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FIFTY MONTHS POST XIENCE V STENTING PROCEDURE IN THE MID RIGHT CORONARY ARTERY AND IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) EACH WITH ONE 3.0 X 18 STENT, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 WITH SHORTNESS OF BREATH AND ANGINA. THE FUNCTIONAL STRESS TEST PERFORMED WAS POSITIVE FOR MYOCARDIAL ISCHEMIA. ON (B)(6) 2011, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE DRCA INDEX TARGET LESION WITH BALLOON ANGIOPLASTY FOR <50% STENOSIS. THE PATIENT'S CONDITION IS IMPROVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH 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 60603P1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R XIENCE V 3.0 X 18