BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1031139 · Received April 18, 2008

    Report

    Report Number
    3003742446-2008-00060
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    September 5, 2005
    Report Date
    March 24, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBER IS 3003742446-2008-00061. MORE THAN TWO PRODUCTS ARE REPRESENTED IN THIS REPORT. HOWEVER, THE NUMBER OF STENTS REPORTED IS UNK.

    Description of Event or Problem · 1

    THE PT HAD SEVERAL STENTS IMPLANTED BETWEEN 2002 AND 2005. IN 2005, THE PT SUFFERED A MINOR HEART ATTACK. IT IS BELIEVED THAT THE PT MAY HAVE RESTENOSIS IN ONE OR MORE OF THE STENTS IMPLANTED. THE NEXT DAY, THE PT HAD ANOTHER CYPHER STENT IMPLANTED. APPROXIMATELY A YEAR LATER (2006), THE PT SUFFERED A MAJOR HEART ATTACK. IT IS BELIEVED THAT THE HEART ATTACK WAS CAUSED BY RESTENOSIS IN THE CYPHER STENT IMPLANTED. THE PT'S PHYSICIAN ATTEMPTED TO TREAT THE IN-STENT RESTENOSIS WITHOUT SUCCESS. THE NEXT DAY, THE PT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) TO CIRCUMVENT THE IN-STENT RESTENOSIS. TWO MONTHS LATER (2006), THE PT SUFFERED ANOTHER MINOR HEART ATTACK. THE NEXT DAY, THE PT UNDERWENT ANGIOPLASTY AND ANOTHER CYPHER STENT WAS IMPLANTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention