BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1954561 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00184
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT COULD CONTRIBUTE TO THE STENT BEING DEPLOYED IN A DIFFERENT LOCATION THAN INTENDED COULD BE INFLUENCED BY, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, AND PROCEDURAL INFLATION TECHNIQUE. IT WAS REPORTED THAT THE STENT WAS NOT DEPLOYED IN THE CORRECT LOCATION; THEREFORE, THE PHYSICIAN USED THE STENT DELIVERY SYSTEM (SDS) TO PUSH THE STENT INTO POSITION AND THE BALLOON MATERIAL INTERACTED WITH THE STENT RESULTING IN THE BALLOON RIPPING AND EMBOLIZING FURTHER DOWN THE VESSEL. THE PATIENT WAS SENT FOR SURGERY; HOWEVER THE SEPARATED PORTION OF THE BALLOON COULD NOT BE FOUND. IN THIS CASE, THE REPORTED BALLOON SEPARATION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE; HOWEVER, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY DEPLOYING THE STENT COULD NOT BE CONFIRMED. TO ENSURE THIS ISSUE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, A SAMPLING OF UNITS IS TESTED TO VERIFY PROPER STENT DEPLOYMENT AND UNIFORMITY OF EXPANSION.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS DISCARDED. THE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    REPORTEDLY AFTER IMPLANTATION OF THE XIENCE V STENT, THE PHYSICIANS WERE NOT PLEASED WITH THE POSITIONING OF THE STENT AND TRIED USING THE STENT DELIVERY SYSTEM BALLOON TO PUSH THE STENT INTO POSITION. THIS RESULTED IN THE BALLOON RIPPING AND EMBOLIZING FURTHER DOWN THE VESSEL. THE PATIENT WAS SENT TO SURGERY TO RETRIEVE THE SEPARATED BALLOON; HOWEVER, THE BALLOON COULD NOT BE LOCATED. THE PATIENT WAS STABLE AFTER THE SURGERY. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R