BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1903854 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02478
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 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, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE LESION CONDITION WAS DESCRIBED AS MODERATELY TORTUOUS AND CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO CROSS. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN, ON THE ENTIRE LENGTH OF THE SHAFT, AND CONTRAST IN THE INFLATION LUMEN. THIS IS CONSISTENT WITH PREPARATION AND USE INSIDE THE BODY. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. DIMENSIONAL ANALYSIS FOUND THE TIP LENGTH AND OUTER DIAMETER OF THE STENT IMPLANT MET MANUFACTURING CRITERIA. IT WAS CONFIRMED THAT THE HYPOTUBE AND JACKET WERE SEPARATED 19 CM DISTAL TO THE STRAIN RELIEF TUBING. THE JACKET MATERIAL WAS STRETCHED AND JAGGED AND THE FRACTURE FACES WERE OVALED 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 SDS MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. THERE WERE ALSO THREE KINKS NOTED IN THE HYPOTUBE, 1.5 CM PROXIMAL TO THE SEPARATION AND 1.3 AND 2.3 CM DISTAL TO THE SEPARATION. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE SDS PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED KINK OR SHAFT SEPARATION. THE SHAFT MOST LIKELY KINKED DURING ADVANCEMENT OF THE CATHETER IN THE DIFFICULT ANATOMY AND FURTHER MANIPULATION OF THE CATHETER WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE REPORTED FAILURE TO CROSS, SHAFT SEPARATION, AND SUBSEQUENT KINKS APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE OF A CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, TWO DIFFERENT XIENCE V STENT DELIVERY SYSTEMS (SDS) WOULD NOT CROSS THE LESION. DURING REMOVAL OF THE 2.75 X 18 MM SDS FROM THE GUIDE CATHETER IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE PHYSICIAN FELT THIS OCCURRED DURING MANIPULATING THE SDS ACROSS THE LESION. A 2.75 X 14 NON-ABBOTT STENT WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT EFFECTS. 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-CLONMEL 0050441

    Patients

    Seq Age Sex Outcome Treatment
    1