BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2920551 · Received January 17, 2013

    Report

    Report Number
    2024168-2013-00324
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABOVE RATED BURST PRESSURE (RBP). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. DISSECTION IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. IT SHOULD BE NOTED THAT THE IFU STATES: DO NOT EXCEED THE LABELED RBP. USE OF PRESSURES HIGHER THAN SPECIFIED MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. 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 THE PROCEDURE WAS TO TREAT A 98% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 3.0 X 23 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE. THE SDS WAS INFLATED ONE TIME AT 18 ATMOSPHERES (ATM), AND THE STENT WAS DEPLOYED. IT WAS THEN NOTED THAT A DISSECTION OCCURRED. THE PATIENT WAS SENT TO SURGERY FOR TREATMENT OF THE DISSECTION AND THE LESION. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25791 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2072041

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R