BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2013346 · Received March 10, 2011

    Report

    Report Number
    2024168-2011-01547
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD ON THE BALLOON AND CONTRAST IN THE INFLATION LUMEN. THIS IS CONSISTENT WITH PREPARATION AND SUGGESTS THE STENT DELIVERY SYSTEM (SDS) HAD BEEN ADVANCED INSIDE THE BODY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THE TIP LENGTH AND STENT IMPLANT OUTER DIAMETER DIMENSIONS MET MANUFACTURING CRITERIA. THE DISTAL END OF THE SOFT TIP WAS TORN AND THERE WERE TWO BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. 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. THERE WERE TWO BENT STRUTS ON THE FIRST ROW AT THE PROXIMAL END OF THE STENT IMPLANT. 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; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ALTHOUGH THE ANATOMICAL CONDITION WAS NOT REPORTED, THE FAILURE TO CROSS IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ADDITIONALLY, DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE PRODUCT. THERE WAS NO REPORT OF ANY DAMAGE TO THE SDS OR STENT IMPLANT PRIOR TO USE, SUGGESTING A PRODUCT QUALITY DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THAT THE STRUTS BECAME DAMAGED AS IT INTERACTED WITH THE TIP OF THE GUIDING CATHETER AND THUS CONTRIBUTED TO THE RESISTANCE MET INSIDE THE GUIDING CATHETER DURING WITHDRAWAL; HOWEVER, SINCE THE GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS, THIS CANNOT BE CONFIRMED. THE RETURNED SDS WAS ABLE TO ADVANCE THROUGH A NEW 6FR GUIDING CATHETER AND WAS REMOVED WITH NO RESISTANCE NOTED. TO ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A PRODUCT DEFICIENCY, THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL SDS ARE 100% VISUALLY INSPECTED ON LINE FOR STENT DAMAGE, INCLUDING AT THE POINT THAT THE PROTECTIVE SHEATH IS PLACED ON THE STENT. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. A DEFINITIVE CAUSE OF THE RESISTANCE BETWEEN THE SDS FROM THE GUIDING CATHETER CANNOT BE DETERMINED. HOWEVER, THE FAILURE TO CROSS, STENT DAMAGE, AND SUBSEQUENT DAMAGE NOTED, APPEAR TO BE RELATED TO OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT: ESTIMATED - THE EVENT WAS REPORTED TO HAVE OCCURRED IN (B)(6), 2011. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE LESION AND DURING WITHDRAWAL FROM THE GUIDE CATHETER EXPERIENCED RESISTANCE, WHICH LED TO FLARED STENT STRUTS. NO ADVERSE PATIENT EFFECTS WERE 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 0082041

    Patients

    Seq Age Sex Outcome Treatment
    1