BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 820569 · Received February 20, 2007

    Report

    Report Number
    9616099-2007-00333
    Event Type
    Death
    Date Received
    February 20, 2007
    Date of Event
    January 15, 2007
    Report Date
    January 26, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. LESION #1-1: THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, OSTIAL, 17.66 MM IN LENGTH, VESSEL DIAMETER 3.0 MM, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A MAVERICK 2.0 X 15 MM BALLOON AT 10 ATM FOR 30 SEC. A CYPHER 3.0 X 18 MM STENT (STENT #1) WAS IMPLANTED AT 14 ATM FOR 25 SEC. THE STENT WAS POST-DILATED WITH A 2.5 X 12 MM BALLOON AT 18 ATM FOR 20 SEC. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 25%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. LESION #1-2: THE TARGET LESION WAS THE PROXIMAL CIRCUMFLEX. THE LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, A BIFURCATION LESION, CALCIFIED, A FLEXION LESION, TORTUOUS, 18 MM IN LENGTH, VESSEL DIAMETER 2.5 MM, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 12 ATM 30 SEC. A CYPHER 2.5 X 28 MM STENT (STENT #2) WAS IMPLANTED AT 10 ATM FOR SEC. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. PLEASE NOTE THAT DEVICE (LOT # I1106034) IS DISTRIBUTED OUTSIDE THE UNTIED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. 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 # 9616099-2007-00333 AND # 9616099-2007-00334.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM AFFILIATE INDICATED THAT APPROXIMATELY NINETEEN (19) DAYS AFTER THE INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED DUE TO A TRANSCERVICAL FRACTURE. A SUB ACUTE THROMBOSIS (SAT) WAS SUSPECTED FROM THE ECG AND BLOOD TESTS. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED IN BOTH OF THE PREVIOUSLY IMPLANTED CYPHER STENTS. BALLOON ANGIOPLASTY WAS DONE TO TREAT THE SAT USING THE KISSING BALLOON TECHNIQUE. THE INFLATION TIMES AND PRESSURES WERE UNKNOWN. TWO (2) DAYS AFTER THE INTERVENTION, THE PATIENT EXPIRED DUE TO HEART FAILURE. AN AUTOPSY WAS NOT DONE. THE PHYSICIAN'S COMMENT REGARDING THE CAUSE OF THE THROMBOTIC EVENT WAS THAT IT WAS DUE TO THE PATIENT'S ANTIPLATELET THERAPY BEING STOPPED BECAUSE OF THE SURGERY PLANNED FOR THE TRANSCERVICAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING (NIQ) NIQ CORDIS DE MEXICO NA I1106034

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| L| R ASPIRIN| MAVERICK 2.0/15MM| TICLID| BALLOON 2.5/12MM