BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 717710 · Received May 17, 2006

    Report

    Report Number
    9616099-2006-00568
    Event Type
    Injury
    Date Received
    May 17, 2006
    Date of Event
    April 20, 2006
    Report Date
    May 17, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIFTEEN (15) POST CYPHER STENT IMPLANTATION, DAYS THE PATIENT HAD A SUB ACUTE THROMBOSIS (SAT). THE PATIENT WAS ASYMTOMATIC. CORONARY ANGIOGRAPHY WAS CONDUCTED PRIOR TO DISCHARGE FOR THE HOSPITAL. THROMBUS WAS OBSERVED AT THE LEVEL OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT WAS THE TARGET VESSEL FOR THE INDEX PROCEDURE. THE PHYSICIAN ATTEMPTED AT TREAT THE SAT USING PTCA, BUT WAS UNABLE TO ADVANCE THE GUIDEWIRE. THUS THE ATTEMPT TO TREAT THE SAT WAS UNSUCCESSFUL. THE FUTURE TREATMENT WILL BE DECIDED BY MONITORING THE VIABILITY. THE PHYSICIAN'S COMMENT REGARDING THE POSSIBLE CAUSE OF THE SAT WAS THAT IT MIGHT HAVE BEEN DUE TO THE STENT BEING UNDER-DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0206073

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R