BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1972075 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00496
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 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, 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 WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN AND ON THE BALLOON, WHICH IS CONSISTENT WITH THE STENT DELIVERY SYSTEM (SDS) ADVANCED OVER A GUIDE WIRE AND ADVANCED INTO THE BODY. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. DIMENSIONAL ANALYSIS FOUND THE TIP LENGTH AND STENT IMPLANT OUTER DIAMETERS MET MANUFACTURING CRITERIA. THE HYPOTUBE WAS SEPARATED, THUS CONFIRMING THE COMPLAINT. THE FRACTURE FACES WERE OVAL SHAPED AS IF KINKED PRIOR TO SEPARATING. THE HYPOTUBE JACKET WAS SEPARATED AT THE SAME LOCATION AND THE JACKET MATERIAL AT THE HYPOTUBE SEPARATION WAS STRETCHED AND JAGGED. 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. 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 THE ATTEMPT TO CROSS AND FURTHER MANIPULATION OF THE CATHETER WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. MULTIPLE KINKS WERE ALSO NOTED THROUGH OUT THE ENTIRE LENGTH OF THE HYPOTUBE. THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURAL ATTEMPTS TO CROSS THE LESION OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE REPORTED FAILURE TO CROSS, KINK, AND SHAFT SEPARATION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION WAS PERFORMED, THE XIENCE V WAS ADVANCED, BUT SOME RESISTANCE WAS MET WHILE INTRODUCING IT INTO THE ARTERY AND THE SHAFT BROKE AROUND 20 - 30 CM FROM THE HUB. THE BREAKAGE OCCURRED ON THE PART OF THE SHAFT THAT WAS OUTSIDE OF PATIENT'S BODY, SO IT WAS EASILY REMOVED FROM THE GUIDE CATHETER. THERE WERE NO PATIENT EFFECTS. THE PATIENT OUTCOME WAS GOOD. 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 0070541

    Patients

    Seq Age Sex Outcome Treatment
    1