BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 929515 · Received October 18, 2007

    Report

    Report Number
    9616099-2007-02055
    Event Type
    Injury
    Date Received
    October 18, 2007
    Date of Event
    September 18, 2007
    Report Date
    September 25, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 1-VESSEL DISEASE WAS FOUND. A STAGED PROCEDURE WAS PLANNED DUE TO TIME/LOGISTICAL REASONS. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN 100MG/DAY, CLOPIDOGREL 100 MG/DAY, STATINS AND OTHER UNSPECIFIED LIPID LOWERING DRUGS. INTRA-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL AND UNFRACTIONATED HEPARIN. THE PRIMARY INDICATION FOR TREATMENT WAS AN ACUTE MYOCARDIAL INFARCTION, KILLIP CLASS IV, WITHIN 72 HOURS OF THE PROCEDURE. THE LOCATION OF THIS NON-ST ELEVATION MYOCARDIAL INFARCTION WAS UNDETERMINED. LVEF WAS >50%. PRE-PROCEDURE CKA AND CK-MB CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. TROPONIN WAS LESS THAN TWO TIMES ABOVE THE UPPER NORMAL LIMITS. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A 75% DE NOVO SAPHENOUS VEIN GRAFT (CLOSEST SEGMENT UNKNOWN) OF 10MM IN LENGTH IN A 3.0MM VESSEL DIAMETER WITH MODERATE TORTUOUSITY OF THE PROXIMAL SEGMENT. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, LITTLE TO NO CALCIFICATION AND WITH THROMBUS ABSENT. DIRECT STENTING WAS PERFORMED WITH A 3.5X13MM CYPHER SELECT PLUS STENT AT 12 ATMOSPHERES (ATM) WITH SATISFACTORY RESULTS. POST-DILATION WAS NOT CONDUCTED. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT DONE. THERE WERE NO PROCEDURAL COMPLICATIONS. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III FLOWS WERE RECORDED PRE AND POST-PROCEDURE. THERE WAS NO RESIDUAL DIAMETER STENOSIS. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 12 MONTHS AND STATINS. POST-PROCEDURE CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. APPROXIMATELY 5 1/2 WEEKS LATER AT THE ONE-MONTH FOLLOW-UP, THE PATIENT WAS ASYMPTOMATIC. MEDICATIONS REMAINED UNCHANGED AND THERE WERE NO ADVERSE EVENTS REPORTED. FIVE MONTHS AFTER THE INDEX, A STAGED PROCEDURE TOOK PLACE. THIS WAS AN 80% OCCLUDED LESION IN THE 1ST DIAGONAL IN A NATIVE VESSEL. PCI WAS PERFORMED WITH AN UNIDENTIFIED STENT AND THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THIS WAS CLASSIFIED AS UNRELATED TO THE STUDY DEVICE AND PROCEDURE. ANGIOGRAPHY DATA ALSO INDICATED 80% RESTENOSIS OF THE BYPASS GRAFT TREATED DURING THE INDEX. IT IS NOT KNOWN IF IT WAS TREATED AND ADD'L INFO HAS BEEN REQUESTED. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. IT IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADD'L INFO RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, RESTENOSIS WAS IDENTIFIED IN THE PREVIOUSLY IMPLANTED 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 DE MEXICO NA I0107053

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L