BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1870233 · Received October 11, 2010

    Report

    Report Number
    2024168-2010-02133
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 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
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: REPORTEDLY, THE LESION WAS IN THE SAPHENOUS VEIN GRAFT. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY LESION. IT IS UNKNOWN HOW IMPLANTING THE XIENCE V STENT IN THE SVG CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. 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, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. IT WAS NOTED THAT THE LESION WAS TIGHT AND WAS NOT PRE-DILATED. THE IFU FURTHER INSTRUCTS THE USER TO PRE-DILATE THE LESION WITH A PTCA CATHETER. IT IS POSSIBLE THAT AN INTERACTION WITH THE TIGHT LESION IN ADDITION TO NO PRE-DILATATION LIKELY CONTRIBUTED TO THE DIFFICULTY CROSSING. THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURES. IT WAS FURTHER REPORTED THAT THE SDS WAS REMOVED AFTER THE INITIAL ATTEMPT TO CROSS, THE LESION WAS DILATED AGAIN, AND THE STENT DELIVERY SYSTEM (SDS) RE-INSERTED, HOWEVER, THE SDS STILL WOULD NOT CROSS AND DURING REMOVAL OF THE SDS FROM THE ANATOMY, RESISTANCE WAS FELT, AT WHICH POINT THE DEVICE WAS PULLED AND THE STENT DISLODGED FROM THE BALLOON. THE IFU STATES THAT AN UNEXPANDED STENT MAY BE RETRACTED NOT THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. FURTHERMORE, SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING WITHDRAWAL OF THE CORONARY STENT SYSTEM, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. THE SDS AND GUIDING CATHETER WERE NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE DETERMINATION OF A CAUSE OF THE REPORTED DIFFICULTIES. HOWEVER, SINCE THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT OR SDS PRIOR TO USE, THIS SUGGESTS A PRODUCT QUALITY DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES, STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. NO INTERVENTION WAS PERFORMED TO RETRIEVE THE STENT AND IT REMAINS IN THE PATIENT ANATOMY. THE LESION WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. THE FAILURE TO CROSS, DIFFICULTY TO REMOVE, AND STENT DISLODGEMENT APPEAR TO BE RELATED TO CASE CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING 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 TWO LESIONS WERE PRESENT IN THE TIGHT AND DISTAL SAPHENOUS VEIN, BUT ONLY THE DISTAL LESION WAS BEING TREATED. AN ATTEMPT WAS MADE TO ADVANCE THE XIENCE V ADVANCE SYSTEM WITHOUT PRE-DILATATION; HOWEVER, THE STENT SYSTEM COULD NOT ADVANCE TO THE LESION. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY, DILATATION WAS PERFORMED, AND THE STENT SYSTEM WAS RE-INSERTED BUT COULD NOT ADVANCE THROUGH THE PROXIMAL LESION. AN ATTEMPT WAS MADE TO REMOVE THE STENT SYSTEM FROM THE ANATOMY; HOWEVER, RESISTANCE WAS FELT. AFTER SEVERAL ATTEMPTS TO REMOVE THE STENT SYSTEM FROM THE ANATOMY, THE DEVICE WAS PULLED AND THE STENT DISLODGED FROM THE BALLOON. THE STENT SYSTEM WITH THE BALLOON ATTACHED WAS REMOVED FROM THE ANATOMY. THE STENT REMAINED IN AN UNKNOWN LOCATION IN THE ANATOMY; NO INTERVENTION WAS PERFORMED TO RETRIEVE THE STENT. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY ONLY. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 0051841

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other