BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3232438 · Received July 18, 2013

    Report

    Report Number
    2024168-2013-04494
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DISLODGED STENT IMPLANT WAS RETURNED, THUS CONFIRMING THE COMPLAINT. BASED ON VISUAL AND DIMENSIONAL ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UN-PACKAGING OF THE 4.0 X 18 MM XIENCE V STENT DELIVERY SYSTEM (SDS), THE DEVICE WAS REMOVED FROM THE TUBING. THE STYLET AND PROTECTIVE SHEATH WERE REMOVED TOGETHER. IT WAS NOTED THAT THE STENT WAS NOT ON THE SDS BALLOON, BUT REMAINED ON THE STYLET. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE STYLET OR THE SHEATH. A NEW 4.0 X 18 MM XIENCE V SDS WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335710 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2041041

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR