BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER CLINICAL 2.50 X 23MM

    MDR report key: 1021020 · Received March 26, 2008

    Report

    Report Number
    9610978-2008-00079
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    October 22, 2003
    Report Date
    October 22, 2003
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS CASE WAS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CYPHER SIROLIMUS-ELUTING CORONARY STENT. A REPORT WAS RECEIVED FROM THE STUDY THAT A PATIENT HAD A 6-MONTH FOLLOW UP CORONARY ANGIOGRAPHY AND HAD A RE-PTCA TO THE TARGET LESION. THE PATIENT DID NOT HAVE ANY ANGINA. A 2.5MM X 23MM CLINICAL CYPHER WAS IMPLANTED DURING THE INDEX PROCEDURE. NO OTHER DETAILS HAVE BEEN PROVIDED. THE LESION THAT WAS REVASCULARIZED WAS SEGMENT 14, AN OBTUSE MARGINAL BRANCH. A DEVICE HISTORY REPORT REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. BASED ON THE VERY LIMITED INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT OTHER THAN THE FACT THAT IS AN INHERENT RISK TO THE PROCEDURE.

    Description of Event or Problem · 1

    THIS IS AN INITIAL AND FINAL REPORT. THE FOLLOWING INFORMATION WAS RECEIVED FROM THE STUDY: THE PATIENT WAS HOSPITALIZED WITHOUT ANGINA. DURING THE 6 MONTH FOLLOW UP VISIT THE PATIENT HAD A RE-ANGIOGRAM AND HAD A SUCCESSFUL TARGET LESION REVASCULARIZATION WITH PLAIN OLD BALLOON ANGIOPLASTY. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER CLINICAL 2.50 X 23MM NONE NIQ CORDIS EUROPA, N.V. NA R0902909

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| R