BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1133681 · Received August 20, 2008

    Report

    Report Number
    9616099-2008-02037
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT HAD A STENT IMPLANTED IN A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED DISTAL END OF THE MID LEFT ANTERIOR DESCENDING. THE LESION WAS A RESTENOSIS DUE TO A PREVIOUS BALLOON ANGIOPLASTY. A PERCUTANEOUS CORONARY INTERVENTION WAS DONE TO TREAT THE TARGET LESION, WHICH WAS PREVIOUSLY LEFT UNTREATED DUE TO A WIRE GOING INTO A FALSE LUMEN. THERE WERE TWO CYPHER STENTS (3.5 X 18MM AND 3.5 X 33MM), WHICH HAD BEEN PREVIOUSLY IMPLANTED FORM THE LEFT MAIN TRUNK TO THE END OF THE MID LEFT ANTERIOR DESCENDING TO TREAT A CHRONIC TOTALLY OCCLUDED VESSEL. A GUIDING CATHETER WAS ENGAGED TO THE TARGET VESSEL AND A GUIDEWIRE WAS INTRODUCED WITH A SUPPORT WIRE, BUT THE GUIDEWIRE WOULD NOT ADVANCE TO THE TARGET LESION BECAUSE IT KEPT GOING INTO THE FALSE LUMEN. THE TARGET LESION WAS FINALLY CROSSED WITH ANOTHER GUIDEWIRE AND A 2.0 X 20MM BALLOON WAS USED TO PRE-DILATE THE LESION AT 14 ATM TWO TIMES. A 2.5 X 18MM CYPHER STENT WAS DELIVERED, BUT IT WOULD NOT CROSS THE LESION BECAUSE IT BECAME CAUGHT IN THE ALREADY IMPLANTED CYPHER STENT. THE LESION WAS AGAIN PRE-DILATED WITH A 2.75 X 21 MM BALLOON AT 18 ATM 5 TIMES. THEN THE CYPHER WAS RE-DELIVERED BUT THE UNIT DID NOT CROSS. SOME FRICTION WAS ENCOUNTERED WHEN THE CYPHER WAS BEING WITHDRAWN THROUGH THE PREVIOUSLY IMPLANTED CYPHERS IN THE LEFT MAIN TRUNK TO THE DISTAL END OF THE MID LEFT ANTERIOR DESCENDING. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DELIVERY SYSTEM BACK INTO THE GUIDING CATHETER CAUTIOUSLY, BUT THE CYPHER COULD NOT BE RETRIEVED INTO THE GUIDING CATHETER AS IT BECAME CAUGHT AT THE TIP OF THE GUIDING CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BALLOON ANGIOPLASTY USING THE 2.0 X 20MM BALLOON USED TO PRE-DILATE THE LESION. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

    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 13404735

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR A 6F LAUNCHER GUIDING CATHETER| A FINECROSS SUPPORT WIRE| NEICHE SAPPHIRE BALLOON AND AN| A CONQUESTPRO GUIDEWIRE| NC SPRINGER BALLOON WERE USED DURING THE PROCEDURE| A RUNTHROUGH HP GUIDEWIRE