BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3222665 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04331
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    November 1, 2012
    Report Date
    June 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) - STENT WAS DEPLOYED ABOVE THE RATED BURST PRESSURE (RBP). ESTIMATED DATE OF EVENT, REPORTED AS (B)(6) 2012. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND BRADYCARDIA ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THAT THE IFU STATES DO NOT EXCEED THE LABELED RBP OF 16 ATM. 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 ON (B)(6) 2011 THE PATIENT UNDERWENT STENTING IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH ONE XIENCE V STENT AT 20 ATMOSPHERES (ATMS). IN (B)(6) 2012, "CARDIAC ARREST OCCURRED SOMETIMES." ALL THE EPISODES OF CARDIAC ARREST OCCURRED IN (B)(6) 2012. PALPITATIONS WERE FELT. THE PATIENT WAS HOSPITALIZED. THE PATIENT HAD UNSTABLE ANGINA AND BRADYCARDIA THAT WAS TREATED WITH THE IMPLANTATION OF A PACEMAKER IN (B)(6) 2012. THE CONDITION RESOLVED. AN ANGIOGRAM WAS NOT PERFORMED. THE PATIENT IS CURRENTLY ALIVE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323223 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0072041

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R ASPIRIN, CLOPIDOGREL