BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884884 · Received October 15, 2010

    Report

    Report Number
    2024168-2010-02156
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED PRODUCT NOTED BLOOD ON THE SHAFT, BALLOON, AND STENT IMPLANT, AND CONTRAST ON THE SHAFT. THIS IS CONSISTENT WITH USE INSIDE THE BODY. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THE TIP LENGTH AND STENT IMPLANT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE HYPOTUBE HAD SEPARATED 21.2 CM DISTAL TO THE STRAIN RELIEF TUBING AND THE HYPOTUBE JACKET WAS STRETCHED AND SEPARATED AT THE SAME LOCATION. THE FRACTURE FACES WERE OVAL SHAPED AS IF THE HYPOTUBE WAS KINKED PRIOR TO SEPARATING. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE STENT DELIVERY SYSTEM (SDS) MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. THERE WERE MULTIPLE KINKS AND BENDS IN THE HYPOTUBE WHICH WERE NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURAL ATTEMPT TO CROSS THE LESION. FURTHER MANIPULATION OF THE CATHETER WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. ADDITIONALLY, IT WAS REPORTED THAT THE SDS WAS DIFFICULT TO REMOVE FROM THE GUIDING CATHETER. IT IS POSSIBLE THAT THE KINKS AND BENDS NOTED AND/OR INTERACTION WITH OTHER DEVICES IN THE GUIDING CATHETER MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY REMOVING THE SDS. THE GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED FOR EVAL, THUS, A CAUSE OF THE DIFFICULTY TO REMOVE CANNOT BE DETERMINED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ALTHOUGH, THE ANATOMICAL CONDITION WAS NOT REPORTED, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND IS LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IN THIS CASE, THE FAILURE TO CROSS, SHAFT SEPARATION, AND SUBSEQUENT KINKS AND BENDS, APPEAR TO BE RELATED TO OPERATIONAL CONTEXT; HOWEVER, A DEFINITIVE CAUSE OF THE DIFFICULTY REMOVING THE SDS FROM THE GUIDING CATHETER COULD NOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFIRMING MATERIAL RECORDS ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT CROSS AND THE HYPOTUBE BROKE AND IT WOULD NOT COME OUT OF THE 7FR GUIDING CATHETER. A NON-ABBOTT STENT CROSSED THE LESION. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0051241

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR STENT: ENDEAVOR