BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1890302 · Received October 22, 2010

    Report

    Report Number
    2024168-2010-02229
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN ADDITION, POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT ARE, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PRODUCT PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PRODUCT PREPARATION, AN INTERACTION WITH THE PT ANATOMY, OR FROM AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT AND/OR ACCESSORY DEVICES. REPORTEDLY, THE STENT DISLODGEMENT IN THE GUIDING CATHETER DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS). HOWEVER, SINCE THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. BASED ON THE INFO PROVIDED, THE LESION WAS MODERATELY TORTUOUS AND HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTY CROSSING AND SUBSEQUENT STENT DISLODGEMENT. IT IS LIKELY THAT DURING ATTEMPTED ADVANCEMENT, THE STENT WAS LOOSENED AND BECAME DISRUPTED ON THE BALLOON DUE TO AN INTERACTION WITH THE HEAVILY CALCIFIED LESION, SUCH THAT UPON WITHDRAWAL, THE STENT DISLODGED IN THE GUIDING CATHETER. 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 THIS COMPLAINT. ADDITIONALLY, ON-LINE TEST DATA FOR THIS LOT SHOWS ALL UNITS PASSED THE MFG CRITERIA. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MFG LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST ATTEMPT TO TREAT THE VESSEL WITH THE XIENCE V 3.5/28 FAILED, DESPITE A PRE-DILATATION WITH A NON-ABBOTT BALLOON. THE STENT COULD NOT CROSS THE TARGET LESION AND DISLODGED IN THE GUIDING CATHETER DURING WITHDRAWAL. THE GUIDING CATHETER WAS CHANGED TO A BIGGER SIZE, AND AN ATTEMPT WAS MADE TO CROS THE MULTILINK VISION 3.5/15, BUT STILL WITHOUT SUCCESS. A SECOND TRY WITH ANOTHER XIENCE V 3.5/28 FINALLY WORKED AFTER USING A LARGER NON-ABBOTT BALLOON IN ADVANCE. NOTHING REMAINS IN THE PT. ALL DEVICES WERE DISCARDED. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0060241

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR STENT: MULTILINK VISION 3.5/15| DILATATION CATHETER: 2.0 MAVERICK| STENT: XIENCE V 3.5/28| DILATATION CATHETER: 3.0 MAVERICK