BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 673953 · Received February 8, 2006

    Report

    Report Number
    9616099-2006-00116
    Event Type
    Death
    Date Received
    February 8, 2006
    Date of Event
    January 6, 2006
    Report Date
    February 8, 2006
    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

    THE PT DEVELOPED CARDIOGENIC SHOCK AND DIED WITHIN 24 HOURS AFTER THE PROCEDURE. PCI WAS PERFORMED ON THIS PT WHO PRESENTED FOR EMERGENT TREATMENT OF TWO LESIONS DUE TO AN ACUTE MYCARDIAL INFARCTION. FIRST WAS TOTALLY OCCLUDED A DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX OF 20MM IN LENGTH IN A 2.8MM VESSEL DIAMETER. THE (CLASS C) ECCENTRIC LESION WAS AT A BIFURCATION, WITH A PRE-EXISTING CLOT AND CALCIFIED. TREATED NEXT WAS A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY OF 17MM IN LENGTH IN AN UNKNOWN VESSEL DIAMETER. THE (B2) ECCENTRIC LESION ALSO HAD A FLEXION. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN 162MG/DAY, HEPARIN 10,000 UNITS AND TICLOPIDINE HYDROCHLORIDE 200MG/DAY. ASPIRATION WAS CONDUCTED FOR THE FIRST LESION (PROIXIMAL LEFT CIRCUMFLEX) BEFORE DEPLOYING ONE 2.5X23MM CYPHER STENT AT 10 ATM BY DIRECT STENTING. POST-DILATION WAS CONDUCTED WITH A 3.0X12MM BALLOON AT 16 ATM FOR UNSPECIFIED REASONS. IVUS WAS CONDUCTED. TIMI 0 AND III FLOWS WERE RECORDED PRE AND POST-PROCEDURE RESPECTIVELY. ACT MEASURED 220-230. RESIDUAL DIAMETER STENOSIS MEASURED 0%. TREATED NEXT WAS THE SECOND LESION (PROXIMAL LEFT ANTERIOR DESCENDING ARTERY) FOR WHICH A 3.0/28MM CYPHER WAS DEPLOYED BY DIRECT STENTING AT 10 ATM. POST-DILATION WAS CONDUCTED WITH A 3.0X12MM BALLOON AT 18 ATM. IVUS WAS CONDUCTED. TIMI III FLOWS WERE RECORDED PRE AND POST-PROCEDURE. ACT MEASURED 220-230. RESIDUAL DIAMETER STENOSIS MEASURED 0%. WITHIN 24 HOURS OF THE PROCEDURE, THE PT DEVELOPED CARDIOGENIC SHOCK. THE PT WAS RESUSCITATED AND INTUBATED. VASOPRESSOR WAS ADMINISTERED BUT THE PT PASSED AWAY. CAB WAS NOT CONDUCTED SO THROMBUS WAS NOT CONFIRMED.

    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 I1005162

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H| L| R