BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2152018 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04791
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    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. GUIDE WIRE: 0.014*3. GUIDE CATH: 6 F EBC 4.0. SHEATH: RRA. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE SHAFT, BALLOON AND STENT IMPLANT, CONSISTENT WITH THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE HYPOTUBE AND JACKET WERE SEPARATED 22.7 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE HYPOTUBE FRACTURE FACE WAS OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THE JACKET WAS STRETCHED AT THE SEPARATION. THERE WERE MULTIPLE OTHER KINKS NOTED TO THE SDS. 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. THE SHAFT LIKELY KINKED DURING ADVANCEMENT IN THE LESION AND FURTHER MANIPULATION OF THE SHAFT OUTSIDE OF THE PATIENT ANATOMY WOULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING AS THERE WAS NO DAMAGE NOTED TO THE SDS PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. 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. 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 TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE AND HYPOTUBE SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR TREATMENT OF A QUADFURCATION LESION OF THE LEFT MAIN ARTERY TO THE CIRCUMFLEX ARTERY USING THE XIENCE V RX CORONARY STENT SYSTEM, THE PHYSICIAN COULD NOT ADVANCE THE XIENCE V RX CORONARY STENT SYSTEM BEYOND THE ASCENDING AORTA. THE SHAFT OF THE STENT SYSTEM SEPARATED WITH NO EXCESSIVE FORCE APPLIED. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW XIENCE V STENT SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT'S CONDITION WAS REPORTED AS STABLE AND THE PATIENT WAS DISCHARGED IN GOOD CONDITION. NO ADDITIONAL INFORMATION HAS BEEN 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 1021741

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR