BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1954501 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00180
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DILATATION CATHETER: 1.3 X 10 MM LAOH, 2.0 X 10 MM TAZUNA, 2.5 X 15 MM AND 3.0 X 15 MM SAPPHIRE; GUIDE WIRE: BMW UNIVERSAL, X-TREAME; GUIDE CATH: 6FR AXESS JL3.5. (B)(4): AGAINST RESISTANCE, DISTAL TO STENT. 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 PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. THE PATIENT ANATOMY WAS REPORTEDLY MODERATELY TORTUOUS AND CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE STENT DISLODGEMENT. AN INTERACTION WITH THE LESION/ANATOMY AND PREVIOUSLY IMPLANTED STENT DURING ADVANCEMENT IN THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE SUBSEQUENTLY LED TO THE STENT DISLODGEMENT. ADDITIONALLY, IT WAS REPORTED THE STENT DELIVERY SYSTEM (SDS) WAS PUSHED AND PULLED IN THE ATTEMPTS TO GET THE SDS TO CROSS THE LESION. IT SHOULD BE NOTED THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: WHEN TREATING MORE THAN ONE VESSEL PER CORONARY ARTERY WITH THESE STENTS, PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS. ADDITIONALLY, THE IFU WARNS THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, REMOVE THE ENTIRE SYSTEM AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. ADDITIONAL TREATMENT WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED STENT DISLODGEMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. TO ENSURE THIS IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERVENTION WAS PERFORMED ON A PATIENT WHO WAS HOSPITALIZED FOR ANGINA. THE TARGET LESION WAS THE LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT WAS MODERATELY TORTUOUS AND CALCIFIED, AND 99% STENOSED. THE VESSEL DIAMETER WAS 2.5MM AND THE VESSEL LENGTH WAS 20MM. AFTER A NON-ABBOTT GUIDE WIRE CROSSED THE CHRONICALLY TOTALLY OCCLUDED LESION IN THE LAD WITH SUPPORT OF A MICRO-CATHETER, PRE-DILATATION WAS PERFORMED WITH 3 NON-ABBOTT BALLOON CATHETERS. A 2.5X18MM XIENCE V STENT DID NOT CROSS THE LESION, THUS ADDITIONAL PRE-DILATATION WAS PERFORMED. A 2.5X18 MM XIENCE V SUCCESSFULLY CROSSED AND WAS IMPLANTED IN THE MID LAD. A 3.0X20 MM NON-ABBOTT STENT WAS IMPLANTED IN THE PROXIMAL LAD, OVERLAPPING THE 2.5X18 MM XIENCE V STENT. AFTER PLACING A BMW GUIDE WIRE IN THE DISTAL LAD, AN ATTEMPT WAS MADE TO GO DISTALLY WITH A 2.5X15 MM XIENCE V, BUT THE STENT CAUGHT ON THE PREVIOUSLY IMPLANTED 2.5X18 XIENCE V STENT. THE DEVICE WAS PUSHED AND PULLED IN AN ATTEMPT TO CROSS, BUT THE 2.5X15 XIENCE V STENT CAUGHT ON THE IMPLANTED STENT AND DISLODGED WHEN THE GUIDING CATHETER DISENGAGED FROM CORONARY. THE DISLODGED STENT WAS CRUSHED AND PRESSED TO VESSEL WALL WITH A NON-ABBOTT BALLOON CATHETER AND ADDITIONAL DILATATION WAS PERFORMED. IT WAS CONFIRMED THAT THE STENT WAS PRESSED TO VESSEL WALL WITH IVUS AND TIMI 3 FLOW WAS ACHIEVED. THE PATIENT IS BEING MONITORED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0082741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S