BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061577 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02713
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH ADVANCING THE STENT DELIVERY SYSTEM (SDS) ONTO A GUIDE WIRE. IT WAS CONFIRMED THAT THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND LOOSE ON THE SHAFT. THE BALLOON WAS TIGHTLY FOLDED WITH CRIMP MARKS BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE TIP LENGTH MET MANUFACTURING CRITERIA. THE FULL LENGTH OF THE STENT IMPLANT WAS SMASHED, THE MIDDLE WAS STRETCHED, THE PROXIMAL END WAS FLARED, AND THERE WAS A BENT STRUT IN THE FIRST ROW OF THE DISTAL END. THE OUTER DIAMETER MEASUREMENTS OF THE STENT IMPLANT WERE NOT TAKEN DUE TO THE DAMAGE. THERE WAS A KINK IN THE DISTAL SHAFT AND MULTIPLE BENDS THROUGHOUT THE FULL LENGTH OF THE HYPOTUBE. ADDITIONALLY, THERE WAS A LONGITUDINAL TEAR IN THE DISTAL EDGE OF THE SOFT TIP. THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND 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 INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE 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. REPORTEDLY, THE ZABO TECHNIQUE WAS PERFORMED. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE (IFU) CAUTIONS: DO NOT PREPARE OR PRE-INFLATE THE DELIVERY SYSTEM PRIOR TO STENT DEPLOYMENT OTHER THAN AS DIRECTED. THE IFU FURTHER CAUTIONS: DO NOT EXPAND THE STENT IF IT IS NOT PROPERLY POSITIONED IN THE VESSEL. IT IS MOST LIKELY THAT BY SLIGHTLY DEPLOYING THE STENT, THE STENT BECAME LOOSENED ON THE BALLOON SUCH THAT THE STENT DISLODGED ONTO THE SHAFT DURING ADVANCEMENT, PRIOR TO REACHING THE LESION SITE. THE FAILURE TO CROSS, STENT DISLODGMENT, AND SUBSEQUENT DAMAGE NOTED DURING PRODUCT ANALYSIS APPEAR TO BE THE RESULT OF OPERATIONAL CONTEXT AND NOT A PRODUCT QUALITY DEFICIENCY. 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 THE REPORTED EVENT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. 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 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 DURING A PROCEDURE OF A BIFURCATION LESION, THE XIENCE STENT WAS ADVANCED TO THE TARGET LESION AND REPORTEDLY THE ZABO TECHNIQUE WAS UTILIZED BY STARTING TO SLIGHTLY DEPLOY THE STENT AND THEN PASS THE GUIDE WIRE THROUGH THE LAST STRUT, DELIVERING THE STENT TO THE BIFURCATION AND THEN FINALLY DEPLOYING THE STENT. HOWEVER, IT WAS NOTED THAT THE STENT DID NOT CROSS THE LESION AND IT DISLODGED OFF THE BALLOON ONTO THE PROXIMAL SHAFT AND WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE PATIENT WAS TREATED SATISFACTORILY WITH A NON-ABBOTT BARE METAL STENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND LOOSE ON THE SHAFT.

    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 0110841

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR