BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021021 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00728
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    August 1, 2005
    Report Date
    August 2, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS RANDOMIZED TO THE PROVISIONAL T-STENTING ARM OF THE STUDY ON A SAFIAN 1A BIFURCATION LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND IN THE 2ND DIAGONAL. PCI WAS PERFORMED ON A 70% DE NOVO LESION IN THE MID LAD (MAIN BRANCH, MB) OF 15MM IN LENGTH IN A 3.5MM VESSEL DIAMETER. THE CONCENTRIC LESION WAS CHARACTERIZED WITH LITTLE TO NO CALCIFICATION AND ANGULATION GREATER THAN 45 DEGREES. IT WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT UNKNOWN INFLATION PRESSURE BEFORE A 3.5 X 18MM CYPHER SELECT PLUS WAS DEPLOYED AT 16 ATMOSPHERES (ATM). THERE WAS NO POST-DILATATION. THE RESIDUAL STENOSIS WAS 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. PCI WAS THEN PERFORMED ON A 90% DE NOVO LESION IN THE 2ND DIAGONAL (SIDE BRANCH, SB) OF 15MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THE CONCENTRIC LESION WAS CHARACTERIZED WITH LITTLE TO NO CALCIFICATION, OSTIAL AND ANGULATION LESS THAN 45 DEGREES. THE LESION WAS PRE-DILATED WITH A 2.5 X15 BALLOON AT 12 ATM. A DISSECTION OCCURRED IN THE SECOND DIAGONAL AND WAS TREATED WITH A 2.5 X 18 MM CYPHER SELECT PLUS AT 12 ATM. THE RESIDUAL STENOSIS WAS 0%. TIMI III FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ELEVATION OF CARDIAC ENZYMES. CK LEVEL WAS 1201 (NORMAL IS 20/195). CK-MB WAS 112.8 (NORMAL IS 0.4/7.0). TROPONIN PEAK WAS 49.83NG/ML (NORMAL IS 01,5). THERE WAS A SLIGHT ST ELEVATION IN V2-V6 - I -AVL. THE MYOCARDIAL INFARCTION (MI) WAS RELATED TO THE TARGET VESSEL AND THE PATIENT WAS TREATED PHARMACOLOGICALLY AND HAD A PROLONGED HOSPITALIZATION, BUT RECOVERED. THE MEDICATIONS AT BASELINE INCLUDED ASPIRIN, TICLOPIDINE, SERUM LIPID LOWERING DRUGS AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDE 7,000 UNITS OF HEPARIN AND MORFIN. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2008-00728 AND 9616099-2008-00729.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT HAD A MYOCARDIAL INFARCTION.

    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 I0505046

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R INTRA-PROCEDURE MEDICATIONS INCLUDE:| SERUM LIPID LOWERING DRUGS| TICLOPIDINE| MORFIN| THE MEDICATIONS AT BASELINE INCLUDED ASPIRIN| BETA-BLOCKERS