BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143330 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04544
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 BALLOON, CONSISTENT WITH THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BUT NOT BETWEEN THE MARKERS, THE DISTAL END OF THE STENT IMPLANT WAS LOCATED 1 MM DISTALLY OVER THE TIP. THE PROXIMAL END OF THE STENT IMPLANT WAS LOCATED 1 CM PROXIMAL TO THE DISTAL BALLOON MARKER. THE DISTAL END OF THE STENT IMPLANT WAS STRETCHED DISTALLY 1 MM OVER THE TIP, FOR A LENGTH OF 1.3 CM. THERE WERE CRIMP MARKS ON THE TIGHTLY FOLDED BALLOON BETWEEN THE PROXIMAL BALLOON MARKER, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE TIP LENGTH, PROXIMAL AND MIDDLE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE DISTAL OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. 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. IN THIS CASE, IT IS LIKELY THAT INTERACTION WITH THE MODERATELY CALCIFIED LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY DURING RETRACTION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE DAMAGED AND MOVED THE STENT ON THE BALLOON AS THERE WAS NO DAMAGE NOTED TO THE STENT DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. 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 STENT MOVEMENT FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE AND NOTED STENT MOVEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY, THE 3.0X28 RX XIENCE V STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE LESION. ANOTHER XIENCE V STENT SYSTEM OF THE SAME SIZE WAS ADVANCED SUCCESSFULLY TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE STENT HAD MOVED AND WAS NOT BETWEEN THE MARKERS.

    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 0080341

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR