BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1935987 · Received December 22, 2010

    Report

    Report Number
    3003742446-2010-00484
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    October 18, 2010
    Report Date
    December 2, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #3003742446-2010-00484, 3003742446-2010-00485, AND 3003742446-2010-00486.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT REPEAT CORONARY ANGIOGRAPHY SHOWED A 20-30% DIAMETER STENOSIS OF THE TWO OF THE CYPHER ((B)(4)/ LOT UNK AND (B)(4)/ LOT UNK) STENTS THAT WERE PLACED, OVERLAPPING, IN THE MID AND PROXIMAL LAD. THIS DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT OF RESTENOSIS. ALSO THE REPORTED MI WAS MOST LIKELY CAUSED BY THE 100% RESTENOSIS IN THE TRANSITION TO THE PREVIOUSLY STENTED BIG OBTUSE MARGINAL BRANCH AND A NEW 70-80% DIAMETER STENOSIS FOUND IN THE RIGHT CORONARY ARTERY, MID VESSEL, AND 40-50% DIAMETER STENOSIS IN THE TRANSITION OF THE MID TO DISTAL RCA. THEREFORE, PLEASE NOTE THAT AS THERE IS NO ALLEGED PRODUCT FAILURE AND THIS FILE WAS INADVERTENTLY SUBMITTED AS A COMPLAINT UNDER THE MEDICAL DEVICE REPORTING REGULATIONS. NO FURTHER REPORTS WILL BE FORTHCOMING FOR MFG. REPORT # 3003742446-2010-00484 AND 3003742446-2010-00485.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR (B)(4) STUDY INDICATED THAT TWO HUNDRED SIX DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO HOSPITAL WITH AN ACUTE MYOCARDIAL INFARCTION. THE INFORMATION STATES THAT THE PATIENT UNDERWENT DEPLOYMENT OF THREE DRUG ELUTING STENTS TO THE MID LAD, THE PROXIMAL LAD, AND THE THIRD OBTUSE MARGINAL BRANCH IN (B)(6) 2010. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LAB FOR A POSSIBLE INFARCT ANGINA. CORONARY ANGIOGRAPHY REVEALED 20-30% DIAMETER STENOSIS IN THE PREVIOUSLY STENTED MID LAD, AND A 30% NATIVE LESION IN THE LAD. THE GROOVE CIRCUMFLEX HAS A 60% STENOSIS AND THERE WAS 100% STENOSIS IN THE TRANSITION TO THE PREVIOUSLY STENTED BIG OBTUSE MARGINAL BRANCH. THERE WAS MINIMAL FLOW DISTALLY. THE RIGHT CORONARY ARTERY REVEALED A 70-80% DIAMETER STENOSIS IN THE MID VESSEL, AND 40-50% DIAMETER STENOSIS IN THE TRANSITION OF THE MID TO DISTAL RCA. THE CIRCUMFLEX MARGINAL LESION WAS TREATED WITH BALLOON ANGIOPLASTY, AND TWO OVERLAPPING DRUG ELUTING STENTS WERE DEPLOYED TO THE PREVIOUSLY PLACED STENT. THE RCA WAS ALSO TREATED WITH BALLOON ANGIOPLASTY AND DEPLOYMENT OF TWO DRUG ELUTING STENTS. THE ACUTE MI EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    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 71 YR Hospitalization| L| R