BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1090783 · Received August 1, 2008

    Report

    Report Number
    9616099-2008-01900
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 4, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE.

    Description of Event or Problem · 1

    THIS PATIENT WAS ADMITTED FOR STABLE ANGINA. OF NOTE THE PATIENT WAS ON A VITAMIN K ANTAGONIST FOR KNOWN CARDIAC EMBOLI. ANGIOGRAPHY REVEALED A 70%, 21MM IN-STENT RESTENOSIS WITH A PREVIOUSLY PLACED DRIVER STENT IN THE PROXIMAL RCA. THE LESION WAS PREDILATED WITH A 3.5 X 15MM BALLOON INFLATED TO 14 ATMS. A 3.5 X 23MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 20 ATMS WITH GOOD RESULTS. THE STENT WAS THEN POST DILATED WITH A 4.0 X 9MM BALLOON INFLATED TO 20 ATMS TO ENSURE COMPLETE EXPANSION. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AS PER THE STUDY DATABASE: IT WAS REPORTED THAT THE PATIENT SUFFERED A STROKE. THE DATE OF THE EVENT IS NOT KNOWN AT THIS TIME. IT IS ALSO UNDETERMINED IF THIS WAS A HEMORRHAGIC OR ISCHEMIC EVENT. THE EVENT DID REQUIRE MEDICAL OR SURGICAL INTERVENTION AND, AS OF THE DATE OF THE REPORT, IS ONGOING AND UNCHANGED.

    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 I0806170

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R ASPIRIN| PLAVIX| VITAMIN K ANTAGONISTS