BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 602720 · Received May 12, 2005

    Report

    Report Number
    3003742446-2005-01405
    Event Type
    Injury
    Date Received
    May 12, 2005
    Date of Event
    April 25, 2005
    Report Date
    May 12, 2005
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE MONTHS FOLLOWING THE INDEX PROCEDURE, THERE WAS OCCLUSION IN ONE OF THE THREE STENTS TREATED. THIS PATIENT PRESENTED TO CATH AND PRE-PROCEDURE MEDICATIONS INCLUDED ENALAPRIL, ASA AND VYTORIN. THE PRE-PROCEDURE LABS DRAWN WERE AS FOLLOWS: WBC 8.9, RBC 5.3, HGB 16, HCT 46.3, MCV 88, MCH 30.4, MCHC 34.6, RDW 13.9, PLATELET COUNT 233, MPV 10.1, SCR .8 MG/DL, EF 60%; CRP, CK, CK-MB, AND TROPONIN NOT DONE. INTRA-PROCEDURE MEDICATIONS INCLUDED HEPARIN AND NTG. PCI WAS PERFORMED ON A 75% DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX OF 10MM IN LENGTH IN A 3.5MM DIAMETER VESSEL. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS NOT PRE-DILATED BEFORE DEPLOYING ONE 2.5/13MM CYPHER STENT AT 16 ATM WITH SATISFYING RESULTS BY VISUAL ESTIMATE. RESIDUAL DIAMETER STENOSIS WAS NOT AVAILABLE. TIMI III FLOW WAS RECORDED PRE AND POST-PROCEDURE.

    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 X1204464

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R