BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021033 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00734
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    December 22, 2005
    Report Date
    January 5, 2006
    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 PRESENTED TO THE CARDIAC CATHETERIZATION UNIT FOR CORONARY ANGIOGRAPHY. PCI WAS PERFORMED ON A SAFIAN 1A BIFURCATION LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), IN THE MAIN BRANCH (MB) AND IN THE 1ST DIAGONAL, IN THE SIDE BRANCH (SB). IN THE MB, THE 99% DE NOVO LESION WAS 20 MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. THE CONCENTRIC LESION WAS CHARACTERIZED WITH LITTLE TO NO CALCIFICATION AND ANGULATED LESS THAN 45 DEGREES. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) II FLOW WAS RECORDED PRE-PROCEDURE. THE LESION WAS PRE-DILATED WITH A 2.5X20MM BALLOON AT 10 ATMOSPHERES (ATM) BEFORE A 3.0X23MM CYPHER SELECT STENT WAS DEPLOYED AT 20 ATM. THERE WAS NO POST-DILATATION. FINAL KISSING BALLOON WAS DONE WITH A 3X0X20MM BALLOON AT 10 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOW WAS RESTORED POST-PROCEDURE. PCI WAS THEN PERFORMED ON A 90% DE NOVO LESION IN THE 1ST DIAGONAL OF 15MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THE CONCENTRIC LESION WAS CHARACTERIZED WITH LITTLE TO NO CALCIFICATION, OSTIAL AND ANGULATED GREATER THAN 45 DEGREES. TIMI II FLOW WAS RECORDED PRE-PROCEDURE. THE LESION WAS PRE-DILATED WITH A 2.0X20MM BALLOON AT 10 ATM BEFORE A 2.5X18MM CYPHER SELECT STENT WAS DEPLOYED AT 18 ATM. POST-DILATATION WAS DONE WITH A 2.5X20MM BALLOON AT 10 ATM AND FINAL KISSING BALLOON WITH A 2.5X20MM BALLOON AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOW WAS RESTORED POST-PROCEDURE. MEDICATIONS AT BASELINE INCLUDED ASPIRIN, CLOPIDOGREL, CALCIUM ANTAGONISTS, BETA-BLOCKERS AND SERUM LOWERING DRUGS. 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. THIS IS ONE OF TWO DEVICES ASSOCIATES WITH THE REPORTED EVENTS THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2008-00734 AND 9616099-2008-00735.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT EXPERIENCED HYPOTENSION. IT REQUIRED NEW ANGIOGRAPHY THAT SHOWED PERICARDIAL EFFUSION DUE TO CORONARY PERFORATION. THE PERFORATION OCCURRED DURING THE PROCEDURE AND OF AN UNKNOWN CAUSE (NOT AVAILABLE OR NOT DETERMINABLE). TREATMENT INVOLVED MEDICATION ADJUSTMENT, REPEAT ANGIOGRAM AND PROLONGED HOSPITALIZATION. THE PATIENT RECOVERED POST EVENT.

    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 I1005117

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R BETA-BLOCKERS| SERUM LOWERING DRUGS| CALCIUM ANTAGONISTS| MEDICATIONS AT BASELINE INCLUDED ASPIRIN| CLOPIDOGREL