BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001487 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00383
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    October 1, 2007
    Report Date
    January 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE REGISTRY INDICATING THAT APPROX SEVEN MONTHS POST INDEX PROCEDURE (2007) THE PT EXPERIENCE ANGINA PECTORIS. AN ANGIOGRAM WAS PERFORMED CONFIRMING 100% RESTENOSIS AT THE MID LEFT ANTERIOR DESCENDING (LAD) (TARGET LESION) AND DISTAL PERI-STENT RESTENOSIS. THE RESTENOSIS AT THE MID LAD WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND CUTTING BALLOON. AT THE LEFT MAIN (TARGET LESION), DIAMETER STENOSIS WAS 80% WITH PROXIMAL PERI-STENT RESTENOSIS/OSTIAL FOCAL RESTENOSIS NOTED AT THE PROXIMAL LAD (NON-TARGET LESION). THE RESTENOSIS WAS TREATED AT THE LEFT MAIN WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA).

    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 I1106200

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R 3X10 BALLOON CATHETER| 9F GUIDING CATHETER