BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961633 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00298
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 23, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE AND SUBSEQUENT DAMAGE TO THE STENT, AS THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE. IT IS LIKELY THAT THE STENT CAUGHT ON THE CALCIFIED LESION OR TIP OF THE GUIDING CATHETER DURING RETRACTION, FURTHER DAMAGING THE STENT, CONTRIBUTING TO THE DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM (SDS). IT WAS REPORTED THE SDS WAS CONTINUED TO BE REMOVED AS RESISTANCE WAS ENCOUNTERED. IT SHOULD BE NOTED THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: 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. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE THE BALLOON IS CHECKED FOR PROPER FOLD CONFIGURATION, THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE STENT IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR STENT DAMAGE DURING THE MANUFACTURING PROCESS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WANTED TO TREAT THE TARGET LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX) WITH THE XIENCE V. DESPITE PREDILATION, THE STENT DELIVERY SYSTEM (SDS) COULD NOT REACH/CROSS THE TARGET LESION. SO, THE STENT COULD NOT BE DEPLOYED IN THE TARGET LESION. FORCE WAS NECESSARY TO REMOVE THE SDS OUT OF THE PATIENT'S BODY; HOWEVER, IT IS UNKNOWN WHETHER THE RESISTANCE WHICH WAS FELT WAS DUE TO RESISTANCE BETWEEN THE XIENCE V AND THE VESSEL OR IF IT WAS DUE TO RESISTANCE BETWEEN THE XIENCE V AND THE GUIDING CATHETER. THE FORCE USED WAS CONSIDERED NORMAL FORCE AND WAS NOT EXCESSIVE. AFTER THAT THE PHYSICIAN SAW THAT SOME STRUTS WERE FLARED A NEW DEVICE WAS USED. NO NEGATIVE PATIENT EFFECTS WERE REPORTED. THE FAILURE TO CROSS AND SUBSEQUENT RESISTANCE ENCOUNTERED DURING REMOVAL OF THE DEVICE DID NOT CAUSE A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL 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 0091341

    Patients

    Seq Age Sex Outcome Treatment
    1