BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3112702 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03061
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    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). THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. STENT DAMAGE AND DISLODGEMENT WERE CONFIRMED. DIFFICULT TO REMOVE FROM GUIDING CATHETER AND DIFFICULT TO REMOVE FROM INTRODUCER SHEATH COULD NOT BE TESTED DUE TO THE CONDITION OF THE RETURNED DEVICE. A CINE WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST, BUT DID NOT VERIFY OR CONFIRM THE ISSUE; HOWEVER, SIGNIFICANT CALCIFICATION OF THE VESSEL WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL 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. 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 A MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (MRCA) STENTING PROCEDURE, THE HEAVILY CALCIFIED LESION WAS PREDILATED WITH SEVERAL BALLOONS. A 3.5X38MM XIENCE XPEDITION WAS ADVANCED WITH RESISTANCE AND AT TIMES WITH FORCE TOWARD THE LESION. IT WAS NOTED UNDER FLUOROSCOPY THAT THE STENT WAS STARTING TO DISLODGE, SO IT WAS DECIDED TO REMOVE THE STENT DELIVERY SYSTEM (SDS) BY PULLING IT INTO THE GUIDING CATHETER, BUT THE STENT COULD NOT BE PULLED IN. THE GUIDE CATHETER WAS REMOVED AND THE SDS WAS ATTEMPTED TO BE PULLED INTO THE SHEATH, BUT THE STENT DISLODGED. THE SDS WAS REMOVED AND THE STENT WAS SNARED AND REMOVED WITH THE SHEATH. UPON REMOVAL, THE PROXIMAL END OF THE STENT APPEARED CRUMBLED. OTHER DEVICES WERE ATTEMPTED, BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS STOPPED, ALL DEVICES REMOVED. IT WAS DECIDED TO BRING THE PATIENT BACK FOR ROTOBLADING AND STENTING AT A FUTURE TIME. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211929 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112141

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention GUIDE CATH: AL75