BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1190312 · Received October 6, 2008

    Report

    Report Number
    9616099-2008-02395
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES, BUT IS SIMILAR TO US DISTRIBUTED STENT DELIVERY SYSTEMS. THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESIONS WERE THE PROXIMAL AND DISTAL BRANCHES OF THE LEFT CIRCUMFLEX ARTERY. THE LESIONS WERE DE NOVO, HEAVILY CALCIFIED AND SLIGHTLY TORTUOUS. THERE WAS 90% STENOSIS. AFTER DELIVERING THE GUIDEWIRE TO THE LEFT CIRCUMFLEX, A 2.5 X 13 MM CYPHER WAS DELIVERED TO THE LESION VIA DIRECT STENTING; HOWEVER, THE STENT COULD NOT CROSS THE PROXIMAL END OF THE DISTAL LEFT CIRCUMFLEX LESION. THEREFORE, THE PHYSICIAN TRIED TO IMPLANT THE CYPHER AT THE PROXIMAL LEFT CIRCUMFLEX AND INFLATED THE SDS THERE. HOWEVER, THE BALLOON WOULD NOT INFLATE. HE SUSPECTED THAT THE INFLATION DEVICE WAS DEFECTIVE AND EXCHANGED TO A DIFFERENT ONE. HE AGAIN TRIED TO INFLATE THE SDS WITH ANOTHER INDEFLATOR, BUT THE BALLOON WOULD STILL NOT INFLATE. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE CYPHER, BUT FELT FRICTION AT THE TIP OF THE GUIDE DURING REMOVAL. HE THEN PULLED THE SDS BACK INTO THE GUIDE FORCIBLY. AFTER THE SDS WAS RETRIEVED FROM THE PATIENT, THE PHYSICIAN FOUND THE STENT TO BE MISSING. THE DISLODGED STENT WAS FOUND IN THE TRUNK OF THE LEFT MAIN. AS THE STENT REMAINED ON THE GUIDEWIRE, A 2.25 X 15MM BALLOON CATHETER WAS DELIVERED OVER THE WIRE TO THE DISLODGED STENT, BUT DURING DELIVERY, THERE WAS FRICTION ENCOUNTERED BETWEEN THE GUIDE AND THE BALLOON CATHETER. THEN THE GUIDE DISENGAGED AND THE GUIDEWIRE SLIPPED FROM INSIDE OF THE STENT BEFORE THE BALLOON REACHED THE STENT. THE STENT DISLODGED INTO THE AORTA AND WAS FOUND AT THE PERIPHERAL ARTERY OF THE LEFT LEG. THE LESIONS IN THE LEFT CIRCUMFLEX WERE SUBSEQUENTLY TREATED ONLY WITH POBA. THE DISLODGED STENT WAS NOT RETRIEVED AND THE PATIENT WILL CONTINUE TO BE FOLLOWED UP. THE PHYSICIAN FOUND THE SDS BALLOON TO BE RUPTURED AFTER THE PROCEDURE.

    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 13408329

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GUIDEWIRE: RUNTHROUGH| BALLOON CATHETER: HIRYU 2.25/15MM| GUIDING CAHTETER: LAUNCHER 6FR EBU