BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1972048 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00490
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE ENTIRE LENGTH OF THE STENT DELIVERY SYSTEM (SDS), WHICH IS CONSISTENT WITH THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE TIP AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE HYPOTUBE AND JACKET MATERIAL WERE SEPARATED 18.3CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THE HYPOTUBE JACKET WAS STRETCHED AND JAGGED AT THE SEPARATION. THERE WERE MULTIPLE KINKS NOTED TO THE SDS. 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 CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, IT IS POSSIBLE THE SHAFT KINKED DURING ADVANCEMENT IN THE LESION AND FURTHER MANIPULATION DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR MAY HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. 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. THE PATIENT ANATOMY WAS MODERATELY TORTUOUS AND CALCIFIED WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE; HOWEVER, A CONCLUSIVE CAUSE FOR THE NOTED HYPOTUBE KINKS AND SEPARATION COULD NOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

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

    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 0081141

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR