BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1982879 · Received February 9, 2011

    Report

    Report Number
    2024168-2011-00788
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE TIP, CONSISTENT WITH A GUIDE WIRE BEING AT LEAST PARTIALLY LOADED INTO THE LUMEN. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. IT WAS CONFIRMED THAT THE TIP HAD SEPARATED AT THE DISTAL END OF THE DISTAL SEAL AND THE FRACTURE FACES WERE JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE SOFT TIP AND CLEAR GAP WERE STRETCHED AND WRINKLED. THE DISTAL END OF THE TIP WAS SLIGHTLY FLARED; HOWEVER, THIS WAS NOT REPORTED, AND THUS, MAY HAVE OCCURRED DURING THE PROCEDURE, INTERACTION WITH A GUIDE WIRE, OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE STENT DELIVERY SYSTEM (SDS) OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TIP DETACHMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, MANUFACTURING (PROCESSING AND/OR HANDLING), HANDLING DURING REMOVAL FROM PACKAGING, PREPARATION/USE OF THE CATHETER, OR INTERACTION WITH LESION/ANATOMY OR ACCESSORY DEVICES. DURING DEVICE ANALYSIS, A MANDREL WAS ADVANCED THROUGH THE TIP PAST THE PROXIMAL SEAL AND THROUGH THE GUIDE WIRE EXIT NOTCH; HOWEVER, DURING AN ATTEMPT TO ADVANCE THE MANDREL THROUGH THE SEPARATED TIP, THERE WAS RESISTANCE NOTED DUE TO THE WRINKLED INNER MEMBER. A NEW 0.014 INCH GUIDE WIRE WAS BACKLOADED THROUGH THE TIP PAST THE PROXIMAL SEAL AND THROUGH THE GUIDE WIRE EXIT NOTCH AND THERE WAS NO RESISTANCE NOTED. AN ATTEMPT WAS MADE TO BACKLOAD THE GUIDE WIRE THROUGH THE SEPARATED TIP, BUT THERE WAS RESISTANCE NOTED AND THE TIP HAD TO BE MANIPULATED TO GET THE WIRE TO ADVANCE. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THE DISTAL TIP MAY HAVE BEEN KINKED DURING INSERTION OF THE GUIDE WIRE, CAUSING RESISTANCE DURING THE ATTEMPT TO ADVANCE THE GUIDE WIRE. THIS RESISTANCE COULD THEN CAUSE THE TIP TO BECOME FURTHER KINKED, AND THE SUBSEQUENT REMOVAL OF THE PRODUCT LIKELY RESULTED IN THE RESISTANCE NOTED WITH THE TIP BECOMING WRINKLED, STRETCHED, AND ULTIMATELY DETACHING; HOWEVER, THIS CANNOT BE CONFIRMED. A DEFINITIVE CAUSE OF THE REPORTED RESISTANCE DURING THE INSERTION OF THE GUIDE WIRE INTO THE SDS AND DIFFICULTY REMOVING THE GUIDE WIRE FROM THE SDS CANNOT BE DETERMINED. HOWEVER, THE TIP DETACHMENT AND SUBSEQUENT TIP DAMAGE NOTED, APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. 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. 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% VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. FURTHERMORE, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY AND TIP TENSILE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, AFTER PRE-DILATATION, THE XIENCE V STENT SYSTEM WAS ADVANCED BUT MET SLIGHT RESISTANCE ON THE FLEXI GUIDE WIRE PRIOR TO ENTERING THE Y-CONNECTOR OUTSIDE OF THE ANATOMY. WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE STENT SYSTEM FROM THE GUIDE WIRE, STRONG RESISTANCE WAS FELT. THE STENT SYSTEM WAS FLUSHED FROM THE TIP USING A FLUSHING NEEDLE. THE TIP OF THE STENT SYSTEM DETACHED, BUT REMAINED ON THE GUIDE WIRE OUTSIDE OF THE ANATOMY. THE DEVICE WAS REMOVED FROM THE GUIDE WIRE AND ANOTHER XIENCE V STENT SYSTEM WAS SUCCESSFULLY ADVANCED OVER THE SAME GUIDE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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-CLONMEL 0050641

    Patients

    Seq Age Sex Outcome Treatment
    1 FLEXI GUIDE WIRE