BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1901662 · Received November 17, 2010

    Report

    Report Number
    3003742446-2010-00414
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 19, 2009
    Report Date
    October 27, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A DISSECTION AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA, TIA, HIATAL HERNIA, DEPRESSION, OSTEOARTHRITIS AND OBESITY. THE TARGET LESION WAS IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS 80% STENOSED AND DE NOVO. THE LESION WAS NOT PRE-DILATED PRIOR TO THE IMPLANT OF A 3.0MM X 13MM CYPHER STENT AT 14ATMS. AFTER IMPLANT AN EDGE DISSECTION WAS NOTED AND TREATED WITH THE IMPLANT OF A 3.0MM X 8.0MM CYPHER STENT PROXIMAL AND OVERLAPPING TO THE FIRST. THE EVENT RESOLVED WITHOUT FURTHER SEQUEL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DISSECTIONS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THE IFU CAUTIONS THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT ASIDE FROM THE INHERENT RISK OF THE PROCEDURE THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE (B)(6) FEMALE PATIENT WAS PART OF THE (B)(4) STUDY. THE TARGET LESION WAS THE MID RCA. THE LESION WAS DE NOVO AND TORTUOUS. A 3.0 X 13MM CYPHER STENT WAS IMPLANTED. WHEN THE STENT WAS IMPLANTED, A DISSECTION WAS NOTED. IN ORDER TO TREAT THE DISSECTION A 3.0 X 08MM CYPHER STENT WAS IMPLANTED OVERLAPPING THE FIRST CYPHER STENT.

    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) 15029486

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention CLOPIDOGREL, 3.25 X 12MM BALLOON