BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040383 · Received May 6, 2008

    Report

    Report Number
    9616099-2008-01243
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 19, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN ATTEMPT TO BACKLOAD A CYPHER STENT DELIVERY ONTO A BMW STEERABLE GUIDEWIRE, THE CYPHER "GOT STUCK AFTER 5-10 CM" AND COULD NOT BE ADVANCED DOWN THE WIRE AND INTO THE PT. NO ANOMALIES HAD BEEN NOTED ON THE DEVICE PRIOR TO USE AND THE GUIDEWIRE LUMEN HAD FLUSHED NORMALLY. IT WAS NOT REPORTED IF THE SDS HAD TO BE FORCEFULLY REMOVED FROM THE WIRE AFTER IT GOT STUCK, OR REPORTED IF THE SDS HAD TO BE FORCEFULLY REMOVED FROM THE WIRE AFTER IT GOT STUCK, OR IF THE HYDROPHILIC COATING ON THE BMW HAD BEEN KEPT WET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE AND NO PT INJURY OCCURRED. ONE NON-STERILE 3.5/18 MM CYPHER SELECT + STENT DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. INFLATION MEDIA TRACES WERE OBSERVED IN THE INFLATION LUMEN. THE PROXIMAL AND DISTAL STRUTS OF THE STENT WERE SLIGHTLY FLARED. THE GUIDE WIRE LUMEN SECTION INSIDE THE BALLOON SHOWED AN ACCORDION CONDITION THAT PROTRUDED FROM THE DISTAL END OF THE STENT. DUE TO THE ACCORDION SHAFT, THE PROXIMAL AND DISTAL MARKER BANDS WERE MOVED DISTALLY FROM THEIR ORIGINAL POSITION. CROSSING PROFILE MEASUREMENTS OF DISTAL AND PROXIMAL STENT WERE FOUND OUT OF SPEC TOLERANCE LIMITS BECAUSE OF THE FLARED STRUTS. AN ATTEMPT TO INTRODUCE A CORDIS 0.014" GUIDEWIRE LAB SAMPLE IN THE SDS PROXIMAL SECTION OF THE WIRE LUMEN RESULTED IN FREE MOVEMENT OF THE WIRE UNTIL IT REACHED THE ACCORDION SEGMENT OF THE GUIDEWIRE LUMEN. STRONG RESISTANCE WAS EXPERIENCED AT THIS POINT. THE WIRE WAS THEN INTRODUCED INTO THE DISTAL TIP OF THE SDS AND THE SAM RESISTANCE WAS EXPERIENCED WHEN THE WIRE REACHED THE WIRE LUMEN DAMAGE. THE ACTUAL INVOLVED GUIDE WIRE WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE COMPLAINT WAS CONFIRMED. ALTHOUGH THE EXACT CAUSE OF THE DAMAGE CANNOT BE CONCLUSIVELY DETERMINED, IT MAY HAVE OCCURRED AS A RESULT OF THE ATTEMPT TO REMOVE THE SDS THAT WAS STUCK TO THE WIRE. THIS COMPLAINT DOES NOT APPEAR TO BE RELATED TO THE MFG PROCESS; INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED UNITS FROM LEAVING THE FACILITY. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT IT WAS VERY DIFFICULT TO LOAD THE CYPHER ONTO THE WIRE. THEN WHILE ADVANCING, THE PHYSICIAN FELT SOME FRICTION AND THE STENT GOT STUCK AFTER 5-10 CM. THE DEVICE WAS STILL OUTSIDE THE PT AND AS A RESULT THE DEVICE WAS NOT USED IN THE PT. FURTHER INFO INDICATED THAT THERE WERE NO PROBLEMS IDENTIFIED WHILE FLUSHING THE CYPHER, AND NO OTHER ANOMALIES WERE NOTED WITH THE DEVICE. THE UNIT WAS RETURNED FOR EVAL. HOWEVER, DURING VISUAL ANALYSIS, IT WAS IDENTIFIED THAT THE PROXIMAL AND DISTAL STRUTS OF THE STENT WERE SLIGHTLY FLARED. ALSO, THE INNER BODY GUIDE WIRE LUMEN SECTION THAT IS LOCATED IN THE BALLOON SHOWED AN ACCORDIONED CONDITION THAT PROTRUDED ABOUT 1 CM FROM THE STENT DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13298707

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BMW STEERABLE GUIDEWIRE 0.0014