BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2072916 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03008
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    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). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST ON THE SHAFT, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) AT LEAST PARTIALLY ADVANCED OVER THE GUIDE WIRE. THE STENT IMPLANT WAS LOOSE ON THE BALLOON. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE TIGHTLY FOLDED BALLOON, BUT WERE NOT BETWEEN THE MARKERS, DUE TO THE INNER MEMBER BUNCHING. THE BALLOON SEPARATED FROM THE OUTER MEMBER AT THE PROXIMAL BALLOON SEAL, CONFIRMING THE REPORTED SEPARATION. THE MATERIAL AT THE SEPARATION WAS JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD. THE SEPARATED PORTION WAS RETURNED. THE INNER MEMBER WAS SEPARATED 24.8CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE MATERIAL AT THE SEPARATION WAS JAGGED. THE INNER MEMBER WAS BUNCHED DISTALLY FROM THE DISTAL BALLOON MARKER, FOR A LENGTH OF 2MM. THE INNER MEMBER WAS WRINKLED 1.1CM DISTAL TO THE SEPARATION, FOR A LENGTH OF 6MM. THE SHAFT WAS WRINKLED 17CM DISTAL TO THE GUIDE WIRE EXIT NOTCH, FOR A LENGTH OF 1CM. THE INNER DIAMETER OF THE GUIDE WIRE EXIT NOTCH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT WAS REPORTED THE GUIDE WIRE LUMEN OF THE SDS WAS NOT FLUSHED PRIOR TO USE. IT SHOULD BE NOTED THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: FLUSH THE GUIDE WIRE LUMEN WITH HEPNS USING THE FLUSHING TOOL SUPPLIED WITH THE PRODUCT. INSERT THE FLUSHING TOOL INTO THE TIP OF THE CATHETER AND FLUSH UNTIL FLUID EXITS THE GUIDE WIRE EXIT NOTCH. IT IS LIKELY THAT THE COAGULATION OF BLOOD ON THE GUIDE WIRE IN COMBINATION WITH THE GUIDE WIRE LUMEN NOT FLUSHED PRIOR TO USE CONTRIBUTED TO THE REPORTED DIFFICULTIES AS THERE WAS NO DAMAGE NOTED TO THE SDS PRIOR TO USE AND THERE WAS NO RESISTANCE REPORTED DURING REMOVAL OF THE STYLET, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. AS RESISTANCE WAS ENCOUNTERED, IF FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE NOTED INNER MEMBER AND SHAFT BUNCHING. FURTHER HANDLING IN THE ATTEMPTS TO REMOVE THE GUIDE WIRE AS FORCE WAS APPLIED LIKELY CONTRIBUTED TO THE SHAFT SEPARATING AND THE STENT BECOMING LOOSE ON THE BALLOON. IT SHOULD BE NOTED THE IFU STATES: APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND / OR DELIVERY SYSTEM COMPONENTS. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE SDS OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT 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. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT 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 DIFFICULTY REMOVING THE GUIDE WIRE OR SHAFT SEPARATIONS FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - EXCESSIVE FORCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL-MID LEFT ANTERIOR DESCENDING ARTERY. AN ATTEMPT WAS MADE TO INSERT THE GUIDE WIRE INTO THE XIENCE V STENT DELIVERY SYSTEM (SDS), WHILE BOTH DEVICES WERE OUTSIDE THE ANATOMY; HOWEVER, THE DEVICES BECAME STUCK. FORCE WAS USED TO REMOVE THE XIENCE, AND THE SHAFT DETACHED PROXIMAL TO THE BALLOON. IT WAS OBSERVED THAT THE GUIDE WIRE WAS BENT, BUT WAS ABLE TO BE REMOVED FROM THE SDS. IT WAS NOTED THAT THE GUIDE WIRE LUMEN WAS NOT FLUSHED PRIOR TO INSERTING THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER XIENCE, AND THERE WERE NO ADVERSE PATIENT EFFECTS 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 0062141

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: TGV FLOOPY