BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2032037 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02080
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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: THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE 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. THE PATIENT ANATOMY WAS REPORTEDLY TOTALLY OCCLUDED WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE BALLOON, INFLATION LUMEN AND ON THE SHAFT AND HYPOTUBE, CONSISTENT WITH A LEAK WHILE IN THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE STRETCHED STRUTS IN THE FIRST TWO ROWS OF THE DISTAL END OF THE STENT IMPLANT. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP) WHEN FLUID WAS OBSERVED COMING OUT OF A TEAR IN THE BALLOON WITHIN A FOLD 1.5 MM PROXIMAL TO THE PROXIMAL BALLOON MARKER, FOR A LENGTH OF .5 MM. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE LESION/ANATOMY AND/OR GUIDING CATHETER/GUIDE WIRE. TO HELP ENSURE THAT THIS DAMAGE IS NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE VISUALLY INSPECTED FOR DAMAGE, INCLUDING AT THE POINT WHERE THE CATHETER IS INSERTED INTO THE PACKAGING COIL. ADDITIONALLY, ALL PRODUCTS ARE LEAK TESTED PRIOR TO PACKAGING AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE CATHETER BODY INTEGRITY AND RBP PRIOR TO RELEASE. THERE WAS NO REPORT OF ANY LEAKS OR DAMAGE TO THE PRODUCT NOTED DURING VISUAL INSPECTION OR PREPARATION FOR USE WHICH SUGGESTS THE BALLOON WAS NOT DAMAGE PRIOR TO USE. IN THIS CASE, IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR THE OCCLUDED LESION DURING THE ATTEMPT TO CROSS THE LESION OR DURING RETRACTION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED FAILURE TO ADVANCE AND NOTED DAMAGE TO THE BALLOON APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO 2.5 X 28 XIENCE V STENTS WERE UNABLE TO CROSS THE TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY. A 2.0 X 20 TREK BALLOON AND A NON-ABBOTT 2.5 X 30 STENT WERE ABLE TO CROSS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING RETURN DEVICE ANALYSIS, A TEAR WAS OBSERVED IN ONE OF THE XIENCE V BALLOONS.

    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 0121041

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR