BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2230802 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06068
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: BALANCE MIDDLEWEIGHT,WHISPER. INFLATION: MEDTRONIC. GUIDE CATHETER: EBU. SHEATH: CORDIS. 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: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) FOUND BLOOD IN THE GUIDE WIRE LUMEN, ON THE BALLOON AND ON THE STENT IMPLANT, WHICH IS CONSISTENT WITH ADVANCEMENT INTO THE BODY. THERE WAS NO CONTRAST VISIBLE. THE UNDAMAGED STENT IMPLANT WAS STATIONARY BETWEEN THE MARKERS OF THE TIGHTLY FOLDED BALLOON. THE TIP LENGTH AND STENT IMPLANT PROFILE MET MANUFACTURING CRITERIA. THE HYPOTUBE SHAFT WAS SEPARATED 20.3 CM DISTAL TO THE STRAIN RELIEF TUBING, THUS CONFIRMING THE COMPLAINT. THE HYPOTUBE FRACTURE FACE WAS OVAL SHAPED AND THE JACKET WAS TORN AND STRETCHED AT THE SEPARATION, SUGGESTING TENSILE OVERLOAD (MATERIAL FATIGUE/STRESS). 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 TWO KINKS IN THE HYPOTUBE 1.3CM AND 2.5CM DISTAL TO THE SEPARATION, AND A BEND IN THE HYPOTUBE 25 CM DISTAL TO THE SEPARATION. THERE WERE TWO BENDS IN THE HYPOTUBE SHAFT 13 CM AND 20 CM DISTAL TO THE STRAIN RELIEF TUBING, AND A BEND 21 CM PROXIMAL TO THE SEPARATED EDGE. THERE WAS A KINK IN THE HYPOTUBE SHAFT 19 CM TO THE SEPARATED EDGE. TO ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS AND BENDS DURING THE MANUFACTURING PROCESS AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IN THIS CASE, THE SHAFT MOST LIKELY KINKED/BENT DURING ADVANCEMENT OF THE SDS IN THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS ANATOMY, AND FURTHER MANIPULATION OF THE SHAFT WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. FAILURE TO ADVANCE / CROSS THE 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, ACCESSORY DEVICE SUPPORT AND/OR PREVIOUSLY IMPLANTED STENTS; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A PRODUCT DEFICIENCY, THE PROFILE DIMENSIONS ON ALL SDS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. THE LESION WAS DESCRIBED AS HEAVILY CALCIFIED, HEAVILY TORTUOUS, AND 95% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THE DEVICE HISTORY WAS REVIEWED AND A QUERY FOR SIMILAR INCIDENTS WAS PERFORMED FOR THIS LOT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. BASED ON THE REPORTED INFORMATION AND THIS INVESTIGATION, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE PROXIMAL TO MID CIRCUMFLEX (CX) ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED, AND A NON-ABBOTT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS THE LESION. AN ATTEMPT WAS THEN MADE TO CROSS THE LESION WITH A 2.5 X 15 MM XIENCE V SDS, BUT THE DEVICE COULD NOT CROSS AND THE SHAFT BENT. FURTHER DILATATION WAS PERFORMED AND THE 2.25 X 12 MM XIENCE V SDS WAS ADVANCED; HOWEVER, THIS SDS COULD NOT CROSS THE LESION AND THE PROXIMAL SHAFT SEPARATED, OUTSIDE THE ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE. A 2.5 X 8 MM XIENCE V SDS WAS THEN ADVANCED, BUT ALSO DID NOT CROSS THE LESION AND THE SHAFT BENT. ADDITIONAL DILATATION WAS PERFORMED AND A 2.75 X 8 MM XIENCE V STENT WAS IMPLANTED SUCCESSFULLY IN THE MID CX. A 2.5 X 12 MM XIENCE V AND A 3.5 X 12 MM XIENCE V WERE IMPLANTED SUCCESSFULLY IN THE PROXIMAL CX TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 1040641

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR