BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143254 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04540
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) REVEALED BLOOD IN THE GUIDE WIRE LUMEN AND ON THE BALLOON AND SHAFT WITH NO CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS AND A BENT STRUT FACING DISTALLY IN THE THIRD PROXIMAL ROW. THE HYPOTUBE (PROXIMAL SHAFT) WAS SEPARATED DISTAL TO THE STRAIN RELIEF TUBING. THESE OBSERVATIONS ARE CONSISTENT WITH THE REPORTED ADVANCEMENT IN THE ANATOMY AND REPORTED SHAFT SEPARATION. FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE CRIMPED STENT OUTER DIAMETER MEASUREMENTS AND TIP LENGTH MEASUREMENT MET MANUFACTURING CRITERIA. THE LESION WAS REPORTEDLY HEAVILY CALCIFIED AND TORTUOUS SUGGESTING DIFFICULT ANATOMICAL CONDITIONS. ADDITIONALLY, ONLY A SMALLER LENGTH STENT WAS ABLE TO CROSS THE LESION. THE NOTED PROXIMAL STRUT BENT DISTALLY IS MOST CONSISTENT WITH INTERACTION WITH THE LESION CALCIFICATION OR ACCESSORY DEVICES (SUCH AS GUIDING CATHETER TIP) DURING RETRACTION FROM THE ANATOMY. IN REGARDS TO THE SEPARATION, THE HYPOTUBE FRACTURE FACES WERE OVAL-SHAPED AND THE JACKET WAS STRETCHED AND JAGGED AT THE SEPARATION. 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 MULTIPLE BENDS THROUGH OUT THE ENTIRE LENGTH OF THE HYPOTUBE, WHICH MAY HAVE BEEN A RESULT OF THE REPORTED RESISTANCE OR LIKELY HANDLING DURING PACKING/SHIPMENT FOR RETURN. A REVIEW OF THE FINISHED GOODS LOT HISTORY RECORD REVEALED NO NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS FOR PROXIMAL SHAFT SEPARATION. BASED ON THE REPORTED INFORMATION, THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE HEAVILY TORTUOUS AND CALCIFIED LESION, AND DUE TO THE REPORTED RESISTANCE, THE SHAFT LIKELY BECAME KINKED AND EVENTUALLY SEPARATED FROM ADDITIONAL HANDLING. IN MANUFACTURING, ALL SDS ARE INSPECTED FOR SHAFT DAMAGE, CRIMPED STENT DAMAGE AND PROPER CRIMPED STENT PROFILE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE CRIMPED STENT PROFILE AND LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. IT WAS A LONG AND VERY DIFFICULT CASE. AFTER PRE-DILATATION, THE 2.5 X 18 XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WAS UNABLE TO CROSS AND DURING THE ATTEMPT, THE PROXIMAL SHAFT SEPARATED. THE ENTIRE SDS WAS ABLE TO BE REMOVED FROM THE PATIENT AND A SECOND 2.5 X 18 XIENCE V WAS ATTEMPTED, BUT IT ALSO FAILED TO CROSS. A 2.5 X 12 NON-ABBOTT STENT WAS ABLE TO CROSS AND WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. 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 1040841

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR