BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER CLINICAL 3.00 X 18MM

    MDR report key: 736612 · Received July 13, 2006

    Report

    Report Number
    9610978-2006-00265
    Event Type
    Injury
    Date Received
    July 13, 2006
    Date of Event
    October 1, 2005
    Report Date
    July 13, 2006
    Manufacturer
    CORDIS RODEN
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT WAS RANDOMIZED TO THE CLINICAL STUDY IN 2003. THE PT IS A MALE WITH A MEDICAL HISTORY OF DIABETES MELLITUS (NON-INSULIN DEPENDENT), PREVIOUSLY NICOTIN ABUSE (STOPPED IN 1995), HYPERTENSION, HYPERLIPIDEMIA, POSITIVE FAMILY HISTORY, AND A PREVIOUS CABG IN 1990. MEDICATION AT BASELINE INCLUDED ASA, CLOPIDOGREL, HEPARIN, BETA-BLOCKERS, NITRATES, ACE INHIBITORS AND SERUM LIPID LOWERING AGENTS. THE PT WAS HOSPITALIZED IN 2003 WITH STABLE ANGINA CLASS II. THE INDEX PROCEDURE WAS PERFORMED 5 MONTHS LATER. THE TARGET LESION WAS AT THE MID-RCA. THE LENGTH OF TARGET LESION WAS 16MM. THE DIAMETER STENOSIS PRE-PROCEDURE WAS 70%, REFERENCE VESSEL DIAMETER WAS 2.5MM. THE TARGET LESION WAS PRE-DILATED WITH AN UNK DEVICE. POST-PROCEDURE TIMI FLOW WAS GRADE III AND THE DIAMETER STENTOSIS POST-PROCEDURE WAS 0%. CK AND CK-MB VALUES WERE NOT MEASURED POST PROCEDURE. THE PT WAS DISCHARGED 3 DAYS LATER WITH NO EVIDENCE OF ANGINA. PLEASE NOTE: DEVICE (LOT# R0902910) IS A CLINICAL UNIT DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER , IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUMBITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM THE CLINICAL STUDY: APPROX TWO AND HALF YEARS POST INDEX PROCEDURE THE PT WAS HOSPITALIZED WITH UNSTABLE ANGINA IIIB. THE PT UNDERWENT A STRESS TEST, ECG AND ECHO. THIS WAS FOLLOWED BY RE-PTCA OF THE LAD WITH POBA. THE RELATIONSHIP OF THIS EVENT TO THE INDEX PROCEDURE AND DEVICE WAS REPORTED AS UNAVAILABLE AT THE TIME THE REPORT WAS RECEIVED BY CORDIS. IN 2006, THE PT WAS RE-HOSPITALIZED WITH UNSTABLE ANGINA IIIB. AN ANGIOGRAM WAS PERFORMED AND THE TARGET LESION SHOWED 70% DIAMETER RESTENOSIS. THE RESTENOSIS WAS LEFT UNTREATED. APPROX SIX WEEK AFTER, THE PT WAS RE-HOSPITALIZED AND A CABG WAS PERFORMED. THE PT WAS ADMITTED WITH UNSTABLE ANGINA IIIB, A STRESS TEST, ECHO AND ECG WERE PERFORMED. DURING THE CABG THE RIGHT DIAGONALIS AND RIGHT INTERMEDIUS WERE TREATED SUCCESSFULLY. THIS EVENT WAS REPORTED AS UNRELATED TO THE INDEX PROCEDURE AND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER CLINICAL 3.00 X 18MM DRUG-ELUTING STENT NIQ CORDIS RODEN NA R0902910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R CLOPIDOGREL| ASPIRIN| HEPARIN| ACE INHIBITOR NOS| BETA BLOCKING AGENTS