BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1063211 · Received June 17, 2008

    Report

    Report Number
    9616099-2008-01535
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 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.

    Description of Event or Problem · 1

    THIS PATIENT EXPERIENCED VESSEL DISSECTION DURING THE IMPLANTATION OF A CYPHER STENT. THE DISSECTION WAS REPAIRED WITH A NON-CORDIS BARE METAL STENT. VESSEL/LESION CHARACTERISTICS WERE DESCRIBED AS A HEAVILY CALCIFIED AND HIGHLY TORTUOUS 90% IN-STENT RESTENOSIS (UNKNOWN PRODUCTS). APPARENTLY, 2 CYPHER STENTS HAD BEEN SUCCESSFULLY IMPLANTED AND IT WAS DURING IMPLANTATION OF THE 3RD CYPHER IN THE DISTAL RCA THAT THE DISSECTION OCCURRED. THE PHYSICIAN ATTEMPTED TO IMPLANT A 4TH CYPHER TO TREAT THE DISSECTION, BUT WAS UNABLE TO CROSS THE LESION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; IT REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. VESSEL DISSECTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BC: TERUMO'S RYUJIN (2.5/15MM)| GW: RUNTHROUGH| LIBERTY BARE METAL STENT 2.5/8MM| GC: HEARTRAIIL JR