BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053429 · Received May 27, 2008

    Report

    Report Number
    9616099-2008-01400
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    January 21, 2008
    Report Date
    April 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-01401. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY 6 WEEKS POST-PROCEDURE, THE PATIENT RETURNED FOR A PLANNED REANGIOGRAPHY AND WAS EXPERIENCING SILENT ISCHEMIA. APPROXIMATELY 3 MONTHS POST-PROCEDURE, THE PATIENT UNDERWENT A CABG, DUE TO A 90% OSTIAL RESTENOSIS IMMEDIATELY BEFORE THE CYPHER STENTS IN THE RCA. THE REPORT IS FROM THE STUDY. THE PATIENT WAS A FEMALE WITH 2 VESSEL DISEASE. A STAGED PROCEDURE WAS PLANNED AT THE TIME OF THE INDEX PROCEDURE. THE PATIENT HAD A HISTORY OF HYPERTENSION AND PERIPHERAL VASCULAR DISEASE. THE INDICATION FOR THE INDEX PROCEDURE WAS SILENT ISCHEMIA. THE TARGET LESION WAS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE VESSEL DIAMETER WAS 2.8MM AND THE LESION LENGTH 30MM. PRE-PROCEDURE STENOSIS WAS 75% AND TIMI FLOW WAS 3. THE LESION WAS DE NOVO, OSTIAL, IRREGULAR CONTOUR, CONCENTRIC AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.5 X12MM BALLOON AT 8ATM. TWO STENTS WERE IMPLANTED IN THE LESION, OVERLAPPING. A CYPER WAS DEPLOYED AT 17ATM AND POST-DILATED BECAUSE THE STENT WAS NOT FULLY EXPANDED. ANOTHER CYPHER WAS DEPLOYED AT 18ATM. THERE WAS NO PROCEDURAL COMPLICATIONS. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. TWO DAYS POST-PROCEDURE, THE PATIENT HAD THE STAGED PROCEDURE TO TREAT AN 80% STENOSIS IN THE FIRST OBTUSE MARGINAL. THE PATIENT WAS DISCHARGED 6 DAYS POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13274009

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention CLOPIDOGREL| ACE INHIBITORS| MEDICATIONS: ASPIRIN| AND STATINS| AND A 2.5 X 12 MM BALLOON| DEVICES: 6FR GUIDING CATHETER| BETA BLOCKERS| HEPARIN