BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2071551 · Received April 28, 2011

    Report

    Report Number
    3003742446-2011-00211
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    January 11, 2011
    Report Date
    April 2, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LESION TREATED DURING THE RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) WAS IN THE MID LAD AND WAS NOT WITHIN FIVE MM OF THE PREVIOUSLY IMPLANTED CYPHER STENT. THE MID LAD OCCLUSION WAS 100%. BASED ON THE ADDITIONAL INFORMATION RECEIVED THERE IS NO INDICATION THERE WAS ANY IN-STENT-RESTENOSIS (ISR) OR PERI-STENT RESTENOSIS (WITHIN 5 MM). THE COMPLAINT IS BEING CHANGED TO NOT REPORTABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY APPROXIMATELY ELEVEN MONTHS POST INDEX PROCEDURE THE PATIENT UNDERWENT A REVASCULARIZATION." THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A CYPHER 3.0 X 13 MM STENT SUCCESSFULLY IMPLANTED IN THE UNPROTECTED LEFT MAIN CORONARY ARTERY (LMCA) DURING THE STUDY INDEX PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE. APPROXIMATELY TEN AND ONE-HALF MONTHS AFTER THE STUDY INDEX PROCEDURE, CORONARY ANGIOGRAPHY AND RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) WAS PERFORMED. A 40% OCCLUSION WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) AND AN ADDITIONAL CYPHER 2.75 X 12 MM STENT WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15060783

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R