BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1014920 · Received March 13, 2008

    Report

    Report Number
    9616099-2008-00621
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    May 30, 2006
    Report Date
    February 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED PRODUCT. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVAL. ADD'L INFO REC'D WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENTS THAT WERE SUBMITTED UNDER THE FOLLOWING MFG #S 9616099-2008-00621 AND 9616099-2008-00622.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, DURING THE 3-YR F/U, THE PT ADVISED THAT HE WAS HOSPITALIZED FOR A MYOCARDIAL INFARCTION, WHICH REQUIRED PERCUTANEOUS CORONARY INTERVENTION (PCI). ADD'L DETAILS REGARDING THIS EVENT ARE NOT CURRENTLY AVAILABLE. THIS PT WAS RANDOMIZED TO THE CYPHER ARM OF THE STUDY. HIS MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA, CURRENT SMOKER, INSULIN DEPENDENT DIABETES MELLITUS, PREVIOUS PCI WITH STENTING AND A BODY MASS INDEX (BMI) OF 25. PRE-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL, ASPIRIN, BETA-BLOCKERS, REOPRO AND HEPARIN. INTRA-PROCEDURE MEDICATIONS INCLUDED HEPARIN. PCI WAS PERFORMED ON A TOTALLY OCCLUDED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) OF 20 MM IN LENGTH IN A 3.0 MM VESSEL DIAMETER WITH MODERATE TORTUOUSITY OF THE PROXIMAL SEGMENT AND A BIFURCATION WITH NO MAJOR SIDE BRANCH INVOLVEMENT. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED WITH AN IRREGULAR CONTOUR. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) 0 WAS RECORDED PRE-PROCEDURE. TWO OVERLAPPING STENTS WERE DEPLOYED BY DIRECT STENTING. A 3.0X23MM CYPHER STENT WAS DEPLOYED AT 10 ATMOSPHERES (ATM) FOLLOWED BY A 3.0X13MM CYPHER STENT AT 14 ATM BOTH WITH SATISFYING RESULTS. THERE WAS NO POST-DILATATION. POST-PROCEDURE CARDIAC ENZYMES WERE AS FOLLOWS: CK 7, CK-MB 4 AND TROPONIN WAS NOT DONE. POST-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL, ASPIRIN, BETA-BLOCKERS AND STATINS. THE PT WAS DISCHARGED WITH ANGINAL COMPLAINTS. AT THE 1-MO F/U, THE PT HAD NO ANGINA COMPLAINTS. ONGOING MEDICATIONS INCLUDED CLOPIDOGREL, ASPIRIN, BETA-BLOCKERS AND STATINS. AT THE 6-MO F/U, THE PT HAD NO ANGINA COMPLAINTS. ONGOING MEDICATIONS INCLUDED CLOPIDOGREL, ASPIRIN, BETA-BLOCKERS, AND STATINS. AT THE 8-MO F/U, THE PT HAD NO ANGINA COMPLAINTS. ONGOING MEDICATIONS INCLUDED CLOPIDOGREL, ASPIRIN, BETA-BLOCKERS AND STATINS. AT THE 12-MO F/U, THE PT HAD NO ANGINA COMPLAINTS. ONGOING MEDICATIONS INCLUDED CLOPIDOGREL, ASPIRIN, BETA-BLOCKERS AND STATINS.

    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 I1003033

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R POST- CLOPIDOGREL| BETA-BLOCKERS| ASPIRIN| INTRA- HEPARIN| BETA-BLOCKERS| ASPIRIN| PRE-PROCEDURE MEDICATIONS INCLUDED: CLOPIDOGREL| HEPARIN| STATINS| REOPRO