BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 642721 · Received October 20, 2005

    Report

    Report Number
    3003742446-2005-01785
    Event Type
    Injury
    Date Received
    October 20, 2005
    Date of Event
    August 6, 2005
    Report Date
    October 20, 2005
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOUR MONTHS AFTER TREATMENT WITH TWO STENTS, THE PATIENT WAS ADMITTED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION AND THERE WAS TOTAL OCCLUSION FOUND IN ONE OF THE STENTS. THIS PATIENT PRESENTED TO CATH WITH AN ACUTE MYOCARDIAL INFARCTION WITHOUT SHOCK. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, UNFRACTIONED HEPARIN, BETA BLOCKER AND ACE INHIBITIRO. INTRO-PROCEDURE MEDICATIONS INCLUDED UNFRACTIONED HEPARIN, PLANNED GP LLB/LLLA INHIBITORS AND PLAVIX (600MG). URGENT PCI WAS PERFORMED ON A 90% DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) OF UNKNOWNLENGTH IN A 3.5MM DIAMETER VESSEL. THE LESION WAS DESCRIBED AS HAVING LITTLE T NO CALCIFICATION. DIRECT STENTING WAS PERFORMED WITH ON E3.5X18MM CYPHER AT UNKNOWN ATM. RESIDUAL DIAMETER STENOSIS MEASURED 0. TIMI III FLOWS WERE RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA 40205842

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R