BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4221476 · Received November 3, 2014

    Report

    Report Number
    2024168-2014-07176
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION, DEVICE DAMAGED BY ANOTHER DEVICE OR MATERIAL DEFORMATION FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. A 2.25 X 12 MM XIENCE V STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THROUGH A DEPLOYED 2.75 X 18 MM XIENCE V STENT IMPLANT, AND BECAME ENTANGLED WITH THE DEPLOYED STENT IMPLANT. THE 2.25 X 12 MM XIENCE V SDS WAS REMOVED WITH RESISTANCE NOTED. THE DEPLOYED 2.75 X 18 MM XIENCE V STENT IMPLANT WAS NOTED TO BE DAMAGED. AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC) WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701954 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4051441

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention STENT: 2.25X12MM XIENCE V