BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132468 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04287
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE ON THE SHAFT, BALLOON AND TIP, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE SOFT TIP WAS COLLAPSED AND TWISTED DISTAL TO THE DISTAL SEAL FOR A LENGTH OF 2 MM, CONFIRMING THE REPORTED TIP DAMAGE. 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. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL SDS ARE 100% VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS AND PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY AND TIP TENSILE FORCE. THE INNER DIAMETER OF THE TIP UP TO THE DAMAGED PORTION AND THE INNER DIAMETER OF THE GUIDE WIRE EXIT NOTCH WERE MEASURED AND MET MANUFACTURING CRITERIA. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. A NEW GUIDE WIRE COULD NOT BE BACK LOADED THROUGH THE SDS DUE TO THE DAMAGE NOTED TO THE TIP. IN THIS CASE, IT IS POSSIBLE THAT THE COAGULATION OF BLOOD ON THE GUIDE WIRE CONTRIBUTED TO THE REPORTED DIFFICULTIES. ADDITIONALLY, AS RESISTANCE WAS MET DUE TO THE BUILD UP OF BLOOD, THIS WOULD CONTRIBUTE TO THE TIP BUNCHING. AND AS THE GUIDE WIRE WAS ATTEMPTED TO BE REMOVED, THIS WOULD CONTRIBUTE TO THE TIP STRETCHING AS THERE WAS NO DAMAGE NOTED TO THE TIP DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULTY POSITIONING/REMOVING THE GUIDE WIRE OR TIP DAMAGE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES EXPERIENCED WITH THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THE REPORTED TIP DAMAGE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. DIFFICULTY WAS NOTED DURING ADVANCEMENT OF THE XIENCE STENT DELIVERY SYSTEM (SDS) ONTO THE WHISPER GUIDE WIRE. THE SDS WAS MOVED BACK AND FORTH, AND RESISTANCE WAS EXPERIENCED; THEREFORE, THE SDS WAS REMOVED, AND RESISTANCE WAS NOTED. AFTER REMOVAL, THE TIP OF THE SDS WAS NOTED TO BE DAMAGED. ANOTHER XIENCE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY, AND THERE WERE NO ADVERSE PATIENT EFFECTS. 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 9111641

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR GUIDE WIRE: WHISPER MS