BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 763253 · Received September 15, 2006

    Report

    Report Number
    9616099-2006-01035
    Event Type
    Injury
    Date Received
    September 15, 2006
    Date of Event
    July 22, 2006
    Report Date
    September 15, 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

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TWO (2) TARGET LESIONS WERE IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE CIRCUMFLEX CORONARY ARTERY. LESION #1 (TL #1): THE LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, 15 MM IN LENGTH, VESSEL DIAMETER OF 3.7 MM, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 3.5 X 20 MM BALLOON AT 25 ATM FOR 20 SEC. A CYPHER 3.5 X 13 MM STENT WAS IMPLANTED AT 22 ATM FOR 20 SEC. THE STENT WAS POST-DILATED WITH A 3.5 X 12 MM BALLOON AT 25 ATM FOR 9 SEC. IVUS WAS NOT DONE. THE RESIDUAL STENOSIS WAS 25%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. LESION #2 (TL #2): THE LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, OSTIAL, 9.2 MM IN LENGTH, VESSEL DIAMETER 3.71 MM, AND TYPE B2. THE LESION WAS PREDILATED WITH A 4.0 X 20 MM BALLOON AT 24 ATM FOR 20 SEC. A CYPHER 3.5 X 23 MM STENT WAS IMPLANTED AT 22 AT FOR 10 SEC. THE STENT WAS POST- DILATED WITH A 4.0 X 20 MM BALLOON AT 24 ATM FOR 20 SEC. IVUS WAS NOT DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. PLEASE NOTED THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2006-01034 AND #9616099-2006-01035.

    Description of Event or Problem · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT APPROXIMATLEY THREE (3) MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND VOMITED. THE PATIENT WAS TAKEN TO A DIFFERENT HOSPITAL THAN WHERE THE INDEX PROCEDURE WAS PERFORMED. ST DEPRESSION WAS NOTED IN ECG. CORONARY ANGIOGRAPHY REVEALED THROMBUS IN THE TWO (2) PREVIOUSLY IMPLANTED CYPHER STENTS. ASPIRATION OF THE THROMBUS WAS DONE AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS ALSO DONE USING A 3.5 X W15 MM BALLOON. TWO (2) DRIVER 4.0 X 18 MM STENTS WERE IMPLANTED INSIDE THE TWO (2) PREVIOUSLY IMPLANTED CYPHER STENTS. THE DRIVER STENTS WERE POST-DILATED WITH A QUANTUM MAVERICK 5.0 X 15 MM BALLOON. THE PHYSICIAN'S COMMENT REGARDING THE POSSIBLE CAUSE OF THE LATE THROMBOSIS WAS THAT IT MAY HAVE BEEN BECAUSE THE STENTS WERE UNDER-DILATED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R HEPARIN| TICLOPIDINE HYDROCHOLORIDE| ASPIRIN| 4.0 X 20 MM BALLOON