BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1000033 · Received February 14, 2008

    Report

    Report Number
    9616099-2008-00341
    Event Type
    Injury
    Date Received
    February 14, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT PRESENTED TO CARDIAC CATHERIZATION WITH ACUTE LATERAL ST EVALUATION MYOCARDIAL INFARCTION WITHIN 6 TO 12 HOURS OF INTERVENTION. THROMBOLYTIC AGENT WAS GIVEN. PRE-PROCEDURE CK AND CK-MB WERE 4 TIMES ABOVE THE UPPER NORMAL LIMITS. TROPONIN WAS 2 TIMES ABOVE THE UPPER NORMAL LIMITS. LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS > 50%. 1 -VESSEL DISEASE WAS FOUND. BLOOD PRESSURE WAS 140/78 AND THE HEART RATE WAS 70. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. PCI WAS PERFORMED ON A 90% DE NOVO LESION IN THE 1ST DIAGONAL OF 18MM IN LENGTH IN A 2.75MM VESSEL DIAMETER WITH MODERATE TORTUOUSITY OF THE PROXIMAL SEGMENT. THE (B1) CONCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, MODERATE CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.0X15MM BALLOON AT 12 ATMOSPHERES (ATM) BEFORE A 2.75X18MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 14ATM WITH SATISFACTORY RESULTS. THERE WAS NO POST-DILATATION. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED AT ANY TIME IN THE PROCEDURE. THERE WERE NO PROCEDURAL COMPLICATIONS. CK, CK-MB AND TROPONIN WERE WITHIN NORMAL LIMITS AT THE 6-24 HOUR INTERVAL POST-PROCEDURE AND ALSO AT THE 24 HOUR-DISCHARGE INTERVAL. ON THE FOLLOWING DAY, THE PT HAD SUB-ACUTE THROMBOSIS IN THE TARGET SITE WAS VERIFIED BY ECG. ONGOING MEDICATIONS AT THE TIME WERE ASPIRIN AND CLOPIDOGREL. THIS EVENT WAS CONSIDERED UNRELATED TO THE STUDY DEVICE AND TO THE INDEX PROCEDURE. IT WAS CONSIDERED A SERIOUS ADVERSE EVENT AND REQUIRED INPATIENT HOSPITALIZATION. THE EVENT WAS RESOLVED ON THE FOLLOWING DAY. ADD'L INFO HAS BEEN REQUESTED. PLEASE NOTE THAT THIS DEVICE (LOT NO. 13264119) IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVAL. ADD'L INFO RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, WITHIN 24 HOURS OF PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PT EXPERIENCED SUBACUTE STENT THROMBOSIS.

    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 13264119

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R CLOPIDOGREL| CLOPIDOGREL| PRE-PROCEDURE MEDICATIONS INCLUDED:| ASPIRIN| ASPIRIN| POST-ASPIRIN| CLOPIDOGREL| INTRA-PROCEDURE MEDICATION INCLUDED: