BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944012 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00633
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED. THE REPORTED TIP SEPARATION WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE DIFFICULTY REMOVING THE STYLET COULD NOT BE REPLICATED AS THE STYLET WAS NOT RETURNED. BASED ON THE VISUAL, DIMENSIONAL, AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, 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. A 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE STYLET FROM THE 2.25 X 12 MM XIENCE V STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS NOTED AND THE TIP OF THE BALLOON BECAME DETACHED FROM THE DEVICE; THEREFORE, THE SDS WAS NOT USED. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE SHEATH. A NEW 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
    48876 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032341

    Patients

    Seq Age Sex Outcome Treatment
    1