BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141765 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04509
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, CH
    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). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED AND FORCE WAS APPLIED. THE XIENCE V INSTRUCTIONS FOR USE 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. APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. IT IS LIKELY THAT THE STENT INTERACTED WITH THE HEAVILY CALCIFIED LESION DURING RETRACTION, CONTRIBUTING TO DAMAGING THE STENT RESULTING IN RESISTANCE DURING RETRACTION AND THE STENT ULTIMATELY DISLODGING. THE DISLODGED STENT WAS NOT RETRIEVED AND REMAINS IN THE PATIENT ANATOMY. TO HELP ENSURE THE REPORTED DIFFICULTIES ARE NOT RELATED TO A MANUFACTURING DEFICIENCY, 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. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INCIDENTS REPORTED FOR DIFFICULT TO REMOVE OR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE, DIFFICULTY REMOVING THE SDS, AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY VIA RADIAL ACCESS, PRE-DILATATION WAS PERFORMED. THE 3.0 X 18 XIENCE V STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE LESION. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE STENT SYSTEM USING FORCE. DURING REMOVAL OF THE STENT SYSTEM FROM THE ANATOMY, RESISTANCE WAS FELT, FORCE WAS APPLIED, AND THE STENT DISLODGED IN THE RADIAL ARTERY. NO INTERVENTION WAS PERFORMED TO RETRIEVE THE STENT FROM THE ANATOMY. A NEW 3.0 X 18 XIENCE V STENT SYSTEM WAS USED TO TREAT THE TARGET LESION SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THOUGH REQUESTED, 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 0110341

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other GUIDE WIRE: PILOT 50