BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1902312 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02413
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V 3.0 X 08 (PART 1009541-08, LOT UNK) AND XIENCE V 3.5 X 08 (PART 1009542-08, LOT UNK) ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE EXIT NOTCH AND TIP. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THIS IS CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM ADVANCED OVER A GUIDE WIRE. THE STENT WAS DISLODGED AND NOT RETURNED, CONFIRMING THE REPORTED INFORMATION. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WAS A BEND IN THE HYPOTUBE AND THE DISTAL EDGE OF THE SOFT TIP WAS SLIGHTLY STRETCHED. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BEND AND TIP DAMAGE MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING ,HANDLING AND RETURN TO ABBOTT VASCULAR. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. 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, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO ADVANCE THROUGH A PREVIOUSLY IMPLANTED STENT, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT SHOULD BE NOTED THAT IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES, "PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS." IN THIS CASE, IT IS LIKELY THAT THE STENT DISLODGEMENT IS RELATED TO USE OF THE PRODUCT, AS THERE WAS NO DAMAGE NOTED DURING INSPECTION PRIOR TO USE. INTERACTION WITH THE TORTUOUS AND CALCIFIED LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE PREVIOUSLY IMPLANTED STENT MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE. FURTHER MANIPULATION OF THE SDS WOULD HAVE RESULTED IN THE STENT ULTIMATELY DISLODGING. IT COULD NOT BE CONFIRMED IF THE DISLODGED STENT REMAINS IN THE PT AND IF IT DID, IT COULD HAVE BEEN COMPRESSED AGAINST THE VESSEL WALL WITH THE ADDITIONAL STENTS OR BALLOONING. THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. 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 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING PRE-DILATATION AFTER TWO XIENCE V STENTS (3.5 X 08 DISTAL FOLLOWED BY A 3.0 X 08) WERE DEPLOYED IN THE RIGHT CORONARY ARTERY, A PERFORATION WAS OBSERVED. ADDITIONAL STENTING WAS PERFORMED. THE XIENCE V 2.75 X 08 DISLODGED AFTER A FAILED CROSS ATTEMPT AND IT COULD NOT BE LOCATED AND IT REMAINED IN THE PT. THE PERCUTANEOUS CORONARY INTERVENTION INVOLVED THE DISTAL RIGHT CORONARY ARTERY (RCA) THAT WAS CALCIFIED AND TORTUOUS. THE PHYSICIAN CHOSE TO STENT PROXIMAL TO DISTAL (CONTRARY TO THE INSTRUCTIONS FOR USE). BEGINNING WITH THE XIENCE V 3.0 X 23, FOLLOWED BY THE 3.5 X 18, 3.0 X 15 AND 3.5 X 08, THE STENTS WOULD NOT CROSS. FINALLY, AFTER TWO XIENCE V STENTS WERE IMPLANTED WITH A 3.5 X 08 DISTAL AND THEN FOLLOWED BY A 3.0 X 08 PROXIMAL TO THAT, A PERFORATION OR WHAT APPEARED TO BE A PERFORATION WAS OBSERVED IN THE MID RCA. THE XIENCE V 2.75 X 08 WAS ATTEMPTED TO BE DEPLOYED DISTALLY; HOWEVER, IT WOULD NOT CROSS THROUGH THE DEPLOYED STENTS AND DISLODGED AND COULD NOT BE LOCATED VIA FLUORO. TWO ADDITIONAL XIENCE V 3.0 X 08 STENTS WERE DEPLOYED AND THE ENTIRE RCA ARTERY WAS BALLOONED PROXIMAL TO DISTAL. IT CANNOT BE CONFIRMED IF THE DISLODGED STENT REMAINS IN THE PT AND IF IT DID, IT COULD HAVE BEEN COMPRESSED AGAINST THE VESSEL WALL WITH THE ADDITIONAL STENTS OR BALLOONING. REPORTEDLY, THE PT IS DOING WELL WITH NO ILL EFFECTS. THROUGH REQUESTED, NO ADDITIONAL INFORMATION 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 9100641

    Patients

    Seq Age Sex Outcome Treatment
    1 Other XIENCE V 3.0 X 08 (PART 1009541-08, LOT UNK)| XIENCE V 3.5 X 08 (PART 1009542-08, LOT UNK)