BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1031140 · Received April 18, 2008

    Report

    Report Number
    9616099-2008-01025
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS JAPAN 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. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH AN 80% LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) BRANCH AND A 90% LESION IN THE DISTAL LAD BRANCH. THE LESION WAS DE NOVO AND HEAVILY CALCIFIED. IT WAS NOTED THAT THE VESSEL WAS SLIGHTLY TORTUOUS. THE DISTAL LAD BRANCH WAS PRE-DILATED AND A 3.0 X 18MM CYPHER STENT WAS BEING DELIVERED TO THE LESION, BUT IT WOULD NOT CROSS THE LESION DUE TO SEVERE CALCIFICATION. THEREFORE, PRE-DILATION WAS CONDUCTED AGAIN, THE SYSTEM WAS EXCHANGED AND THE CYPHER WAS RE-DELIVERED, BUT IT DID NOT CROSS. ALTHOUGH, THE PHYSICIAN COULD NOT CONFIRM CLEARLY UNDER CORONARY ANGIOGRAPHY, SOMETHING RESEMBLING A VESSEL DISSECTION APPEARED AT THE PROXIMAL END OF THE DISTAL LAD. THE DISSECTION PROBABLY OCCURRED WHILE ATTEMPTING TO DELIVER THE CYPHER. IN ORDER TO TREAT THE DISSECTION, THE PHYSICIAN IMPLANTED A 2.5 X 28MM CYPHER. THEN ANOTHER CYPHER WAS IMPLANTED IN THE PROXIMAL LAD AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE.

    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 13350746

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MAJIN BALLOON CATHETER| 6F| JL3.5 LAUNCHER GUIDING CATHETER| THE FOLLOWING PRODUCTS WERE USED DURING PROCEDURE:| RUNTHROUGH NS HYPHERCOAT