BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2182396 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05344
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: SION BLUE, FIELDER. GUIDE CATH: TAIGA AL1.0 SH 6 F. 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, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS MILDLY TORTUOUS AND HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT WAS REPORTED THE STENT DELIVERY SYSTEM (SDS) WAS RE-INSERTED INTO THE ANATOMY AFTER THE FIRST FAILED ATTEMPT TO CROSS, WHICH ALSO MAY HAVE LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT SHOULD BE NOTED THE XIENCE V INSTRUCTIONS FOR USE STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE 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. AN INTERACTION WITH THE CALCIFIED ANATOMY DURING THE MULTIPLE ATTEMPTS TO CROSS THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE TO THE STENT AND SUBSEQUENTLY LEAD TO THE STENT DISLODGEMENT. TO ENSURE THE REPORTED DIFFICULTIES ARE 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. 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 INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INCIDENTS REPORTED FOR STENT DISLODGEMENTS FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE MID CIRCUMFLEX, AND WAS MILDLY TORTUOUS, HEAVILY CALCIFIED, WITH A 90% STENOSIS. THE VESSEL DIAMETER WAS 2.5 MM AND THE VESSEL LENGTH WAS OVER 20 MM. AFTER A GUIDE WIRE CROSSED THE TARGET LESION, A 1.3 X 10 MM NON-ABBOTT BALLOON CATHETER WAS ADVANCED, BUT IT WAS UNABLE TO DELIVER TO THE TARGET LESION; THEREFORE, PRE-DILATATION WAS PERFORMED AT THE SHORT OF THE LESION. THEN ANOTHER DILATATION WAS DONE WITH A 2.25 X 10 MM NON-ABBOTT BALLOON AT 18 ATMOSPHERES (ATM) FOR 30 SECONDS, TWICE, AND INTRAVASCULAR ULTRASOUND WAS PERFORMED. NEXT, A 2.5 X 28 MM XIENCE V WAS ADVANCED, BUT FAILED TO CROSS. ADDITIONAL DILATATION WAS PERFORMED AND A FIELDER GUIDE WIRE WAS ADDITIONALLY INSERTED; HOWEVER, THE XIENCE V DID NOT CROSS THE LESION. A 2.5 X 10 MM NON-ABBOTT DILATATION BALLOON WAS DELIVERED TO THE LESION AND INFLATED AT 6 ATM FOR 30 SECONDS, THREE TIMES, AND ATTEMPTS WERE MADE TO CROSS WITH THE XIENCE V AGAIN; HOWEVER, THE STENT DISLODGED DURING THE DELIVERY INTO THE TARGET LESION. AS THE STENT IMPLANT COULD NOT BE RETRIEVED WITH A SNARE DEVICE, THE DISLODGED STENT WAS IMPLANTED IN THE TARGET LESION USING THE STENT DELIVERY SYSTEM BALLOON. NO PATIENT ADVERSE EVENT WAS REPORTED. 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 0121041

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SEE H10 FOR CONCOMITANT MEDICAL DEVICES