BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 767315 · Received October 2, 2006

    Report

    Report Number
    9616099-2006-01094
    Event Type
    Death
    Date Received
    October 2, 2006
    Date of Event
    October 21, 2005
    Report Date
    October 2, 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

    Additional Manufacturer Narrative · 1

    ADD'L LOT# I0805138, EXP DATE 11/30/2005, MFR DATE 08/2005. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS REPORTED TO BE: DE NOVO, CONCENTRIC, A BIFURCATION LESION, CALCIFIED, VESSEL DIAMETER OF 3.5 MM 40 MM IN LENGTH, AND TYPE C. THE LESION WAS PRE-DILATED WITH AN 3.0 X 20 MM BALLOON AT 8 ATM FOR 30 SEC. A CYPHER 3.0 X 23 MM STENT WAS IMPLANTED AT 20 ATM FOR 30 SEC. AN ADDITIONAL CYPHER 3.5 X 18 MM STENT WAS IMPLANTED AT 20 ATM FOR 30 SEC PROXIMAL TO THE FIRST STENT IN OVERLAPPING FASHION. THE STENTS WERE NOT POST-DILATED. IVUS WAS NOT DONE. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE RESIDUAL STENOSIS WAS 0%. AN ACT WAS NOT MEASURED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #9616099-2006-01094 AND #9616099-2006-01095.

    Description of Event or Problem · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT THREE (3) DAYS AFTER THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND ST -ELEVATION IN LEADS V2-V6 WAS OBSERVED. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENTS - ADVERSE EVENT #1 (AE#1). THE SUB ACUTE THROMBOSIS (SAT) WAS TREATED BY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE PROCEDURE WAS COMPLETED AND THE STENTS WERE PATENT AND NO FLOW PROBLEMS WERE NOTED. AE#2: APPROXIMATELY TWO AND ONE-HALF (21/2) MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS REPORTED TO HAVE SUDDENLY EXPIRED. NO INFORMATION REGARDING AN AUTOPSY OR CAUSE OF DEATH WAS AVAILABLE. THE PHYSICIAN'S COMMENTS REGARDING THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT IT MAY HAVE BEEN DUE TO THE FACT THAT THE CYPHER STENTS WERE UNDER-DILATED. THE PHYSICIAN'S COMMENT REGARDING THE CAUSE OF THE SUDDEN DEATH WAS THAT IT IS UNKNOWN BUT PROBABLY NOT RELATED TO THE CYPHER STENTS.

    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 I0705083

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| R HEPARIN| TICLOPIDINE HYDROCHLORIDE| ASPIRIN| 3.0 X 20 MM BALLOON| SARPOGRELATE HYDROCHLORIDE