BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-SIROLIUS-ELUTING CORONARY STENT

    MDR report key: 734084 · Received June 29, 2006

    Report

    Report Number
    3003742446-2006-00453
    Event Type
    Injury
    Date Received
    June 29, 2006
    Date of Event
    January 3, 2006
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    na
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT FORM THE DATABASE INDICATED THAT: A PATIENT WITH A HISTORY OF CABG WAS ADMITTED FOR A PROCEDURE TO THE GRAFTED VESSEL (SVG TO PROXIMAL RCA) WITH 95% STENOSIS. THE LESION WAS OSTIAL. THE LESION WAS A DE NOVE; CALCIFICATION IS UNKNOWN. PREPROCEDURE, TIMI FLOW WAS 2. A 2.5X28MM CYPHER STENT WAS IMPLANTED AFTER PRERDILATION. POST PROCEDURE, STENOSIS WA 0% AND TIMI FLOW WAS 3. SEVEN MONTHS LATER, THE PATIENT HAD AN ER VISIT FOR DYSPNEA AND POSSIBLE ANGINA. THE FOLLOWING MONTH, THE PATIENT HAD REPEAT ANGIOGRAPHY FOR SOB AND SCAPULAR PAIN. PER REPORTER, THE ANGIOGRAM REVEALED THAT THE VEIN GRAFT WAS OCCLUDED PROXIMAL TO THE PREVIOUSLY DEPLOYED CYPHER STENT; THE PHYSICIAN WHO EXAMINED THE FILMS STATED THAT THE STENT WAS TOTALLY OCCLUDED, HOWEVER. THERE WAS NO INTERVENTION DONE. PREPROCEDURE MEDICATIONS WERE ASPIRIN, BETA BLOCKER, AND ACE INHIBITORS; INTRAPROCEDURE REGIMEN, PLUS STATINS AND 6 MONTHS OF PLAVIX. PER REPORT, THE PROCEDURE WAS A COMPLETE SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-SIROLIUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA Y0305199

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening ACE INHIBITOR NOS| BETA BLOCKING AGENTS