BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141337 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04494
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ABILITY TO CROSS A LESION CAN BE IMPACTED IN NUMEROUS WAYS. SOME OF THE CONTRIBUTING FACTORS MAY CONSIST OF, BUT NOT LIMITED TO, PATIENT ANATOMICAL CONDITION, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. IN THIS CASE, IT WAS REPORTED THAT THE LESION WAS DESCRIBED AS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO CROSS. DURING THE ATTEMPT TO WITHDRAWAL THE SDS, THE XIENCE STENT DISLODGED OFF OF THE BALLOON. HOWEVER, IT WAS REPORTED THAT THE LESION WAS NOT PRE-DILATED PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE XIENCE STENT WAS IMPLANTED WITH OUT PRE-DILATATION (DIRECT STENTING). IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES TO PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. LIMIT THE LONGITUDINAL LENGTH OF PRE-DILATATION BY THE PTCA BALLOON TO AVOID CREATING A REGION OF VESSEL INJURY THAT IS OUTSIDE THE BOUNDARIES OF THE XIENCE V STENT. IT IS POSSIBLE THAT THE LACK OF PRE-DILATATION COULD HAVE CONTRIBUTED TO THE FAILURE TO CROSS AND STENT DISLODGEMENT. IN THIS CASE, IT APPEARS THAT THE STENT MAY HAVE INTERACTED WITH THE ANATOMICAL CONDITIONS AND SUBSEQUENTLY RESULTED IN THE STENT DISLODGEMENT DURING WITHDRAWAL. ALTHOUGH IT WAS STATED THAT ANGIOGRAPHY REVEALED THAT THE GUIDE WIRE HAD BEEN PLACED IN A FALSE LUMEN OF THE VESSEL AND THAT IT MAY HAVE RESULTED IN THE FAILURE TO CROSS; IT IS MOST LIKELY THAT THE ANATOMICAL CONDITIONS AND LACK OF PRE-DILATION WERE THE MAIN CONTRIBUTORS. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY ASSOCIATED WITH THIS LOT. THE REPORTED FAILURE TO CROSS, STENT DISLODGEMENT, ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT AND DEVICE EMBEDDED IN THE VESSEL WALL APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE WAS PLACED ACROSS THE LESION IN A HEAVILY CALCIFIED CIRCUMFLEX, AND THE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE SDS WOULD NOT CROSS. DURING REMOVAL OF THE SDS FROM THE PATIENT, THE STENT DISLODGED IN THE PATIENT ANATOMY. UPON ANGIOGRAPHY IT WAS NOTED THAT THE GUIDE WIRE HAD BEEN PLACED IN A FALSE LUMEN OF THE VESSEL, WHICH COULD HAVE RESULTED IN THE FAILURE TO CROSS; HOWEVER, THIS CANNOT BE CONFIRMED. AFTER PLACEMENT OF THE GUIDE WIRE IN THE TRUE LUMEN OF THE VESSEL A 2.0 X 15 MM DILATATION BALLOON WAS CROSSED AND USED TO CRUSH THE STENT TO THE VESSEL WALL AND A 3.5X18 NON-ABBOTT STENT WAS USED TO SECURE IT IN PLACE. THE PATIENT IS REPORTED TO BE FINE. 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 0020841

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention