BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 624129 · Received August 1, 2005

    Report

    Report Number
    9616099-2005-01197
    Event Type
    Injury
    Date Received
    August 1, 2005
    Date of Event
    July 7, 2005
    Report Date
    August 1, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWELVE HOURS AFTER PCI, THROMBUS WAS FOUND IN THE CYPHER. PCI WAS PERFORMED ON THIS PT WHO EMERGENT TREAT DUE TO AN AMI IN THE MID RIGHT CORONARY ARTERY OF 15MM IN LENGTH IN AN UNKNOWN VESSEL DIAMETER. THE (B2) LESION WAS CHARACTERIZED AS CALCIFIED AND TORTUOUS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASA 100 MG/DAY, 10,000 UNITS OF HEPARIN, TICLOPIDINE HYD 200MG/DAY AND CILOSTAZOL 200MG/DAY. THE LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT 10 ATM BEFORE DEPLOYING ONE 2.5X18MM CYPHER AT 16 ATM. POST-DILATION WAS PERFORMED WITH A 2.5X15MM BALLOON FOR UNSPECIFIED REASONS. IVUS WAS CONDUCTED. TIMI I AND III FLOWS WERE RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. ACT WAS NOT MEASURED BUT APTT WAS BETWEEN 50-80. POST-PROCEDURE MEDICATIONS INCLUDED ASA 100 MG/DAY, TICLOPIDINE HYDROCHOLORIDE 200MG/DAY AND CILOSTAZOL 200MG/DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R