BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2011031 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01524
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED BLOOD ON THE HUB, SHAFT, BALLOON, STENT IMPLANT AND IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN. THIS IS CONSISTENT WITH PREPARATION AND THE SDS ADVANCED INTO THE PATIENT ANATOMY. THERE WERE ALSO KINKS AND MULTIPLE BENDS IN THE HYPOTUBE. THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURAL ATTEMPTS TO CROSS THE LESION OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE TIGHTLY FOLDED BALLOON. HOWEVER, CRIMP MARKS WERE VISIBLE ON THE BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE REPORTED STENT FRACTURE WAS NOT CONFIRMED, AS IT WAS RECEIVED IN ONE PIECE. THE ENTIRE LENGTH OF THE STENT IMPLANT WAS STRETCHED AND MANGLED, WHICH IS CONSISTENT WITH THE REMOVAL VIA A SNARE DEVICE AND MAY HAVE BEEN INADVERTENTLY PERCEIVED AS A STENT FRACTURE. THE STENT IMPLANT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT 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. THE LESION CONDITION WAS DESCRIBED AS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO CROSS. SINCE THERE WAS NO REPORT OF ANY DAMAGE TO THE SDS OR STENT IMPLANT PRIOR TO USE, THIS SUGGESTS A PRODUCT QUALITY DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DISRUPTION AND DAMAGE OF THE STENT ON THE BALLOON. THEN, DURING RETRACTION OF THE SDS, THE DAMAGED STENT STRUTS WOULD HAVE INTERACTED WITH THE ANATOMY AND/OR GUIDING CATHETER, CONTRIBUTING TO THE STENT DISLODGING FROM THE BALLOON. A SNARE DEVICE WAS USED TO RETRIEVE DISLODGED STENT. AFTER THE FIRST XIENCE V WAS SNARED, A SECOND XIENCE V WAS UNABLE TO CROSS, AND A THIRD XIENCE V WAS SUCCESSFULLY IMPLANTED. AT THIS TIME, A PERFORATION WAS OBSERVED IN THE RADIAL ARTERY AND VASCULAR SURGERY WAS PERFORMED AS TREATMENT. PERFORATION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. 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 AND ON-LINE TEST DATA FOR THIS LOT SHOWS ALL UNITS PASSED THE MANUFACTURING CRITERIA. THE STENT FRACTURE WAS NOT CONFIRMED, HOWEVER, THE FAILURE TO CROSS, STENT DISLODGEMENT, AND SUBSEQUENT STENT DAMAGE, KINKS, AND BENDS NOTED DURING PRODUCT ANALYSIS APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. 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% INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE, AND CRIMPED STENT OUTER DIAMETER, AND 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 ACCESS WAS THROUGH THE RIGHT RADIAL ARTERY. DURING ADVANCEMENT OF THE STENT DELIVERY SYSTEM (SDS) IN THE LEFT MAIN TO REACH THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, THE STENT STRIPPED OFF THE BALLOON. A SNARE DEVICE WAS USED IN AN ATTEMPT TO CAPTURE THE DISLODGED STENT FROM THE LEFT MAIN; HOWEVER, DURING REMOVAL, THE STENT FRACTURED IN TWO PIECES AND ONLY THE PROXIMAL PIECE OF THE STENT WAS REMOVED. THE SNARE DEVICE WAS REINSERTED INTO THE PATIENT TO REMOVE THE OTHER PIECE OF STENT; HOWEVER, THE SNARE, SHEATH AND GUIDING CATHETER HAD TO BE REMOVED TOGETHER IN ORDER TO RETRIEVE THE OTHER PIECE OF THE STENT. A NEW SHEATH WAS PLACED WITH A 7FR GUIDING CATHETER TO CONTINUE THE INTERVENTION. A SECOND XIENCE V STENT WOULD NOT CROSS FOR TREATMENT AND WAS REMOVED FROM THE PATIENT. A THIRD XIENCE V STENT WAS ABLE TO BE PLACED SUCCESSFULLY TO COMPLETE THE PROCEDURE. AT THIS TIME IT WAS NOTICED THAT THERE WAS TRAUMA (BLEEDING/PERFORATION) TO THE RADIAL ARTERY, EVIDENCED BY SWELLING OF PATIENT ARM CAUSED BY THE FRACTURED STENT. THE PATIENT WAS SENT TO VASCULAR SURGERY FOR SURGICAL REPAIR OF THE PERFORATION IN THE RADIAL ARTERY. 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 0070541

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R