BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2933772 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00467
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGAINST RESISTANCE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT AND THAT APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING THE PROCEDURE IN THE HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY, A 3.0X23 RX XIENCE V STENT SYSTEM WAS ADVANCED WITH RESISTANCE AND SOME FORCE WAS APPLIED TO THE STENT SYSTEM TO CROSS THE LESION. THE STENT WAS DEPLOYED. AFTER STENT DEPLOYMENT, THE PHYSICIAN OBSERVED A DISSECTION AT THE DISTAL EDGE OF THE STENT. A 3.0X28 XIENCE V STENT WAS DEPLOYED TO COVER THE DISSECTION. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39628 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2072441

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention