BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021165 · Received March 27, 2008

    Report

    Report Number
    9616099-2008-00799
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    November 8, 2007
    Report Date
    March 1, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBER IS 9616099-2008-00800. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROX TWO MOS AFTER INDEX PROCEDURE, THE PT EXPERIENCED A NON Q-WAVE MYOCARDIAL INFARCTION IN AN UNDETERMINED LOCATION. THERE IS NO ADD'L INFO REGARDING THIS EVENT AVAILABLE AT THIS TIME. A MALE PT WAS ENROLLED IN THE STUDY IN 2007 WITH 1-VESSEL DISEASE. THE PT'S MEDICAL HISTORY WAS PREVIOUS PCI, HYPERTENSION, HYPERLIPIDEMIA AND MODERATE TO SEVERE LIVER DISEASE. MAIN INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE 1ST TARGET LESION WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS RESTENOSIS OF A BARE METAL STENT (STEEL, NON-CORDIS), BIFURCATED, NON-OSTIAL, SMOOTH, READILY ACCESSIBLE, ECCENTRIC, NOT CALCIFIED, NO THROMBUS PRESENT, AND A LESION CLASSIFICATION TYPE B1. THE REFERENCE VESSEL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 10MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 80%. TIMI IS UNK. THE LESION WAS NOT PRE-DILATED. A CYPHER WAS DEPLOYED AT 18 ATMS WITH SATISFACTORY RESULTS. POST PROCEDURE STENOSIS WAS 0%. THE 2ND TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS A RESTENOSIS OF A BARE METAL STENT (STEEL, NON-CORDIS). BIFURCATED, NON-OSTIAL, SMOOTH, READILY ACCESSIBLE, CONCENTRIC, NOT CALCIFIED, NO THROMBUS PRESENT, AND A LESION CLASSIFICATION TYPE B2. THE REFERENCE VESSEL DIAMETER WAS 3.3MM AND THE LESION LENGTH WAS 15MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 90%. THE LESION WAS NOT PRE-DILATED. ANOTHER CYPHER WAS DEPLOYED AT 16 ATMS WITH SATISFACTORY RESULTS. POST-PROCEDURE STENOSIS WAS 0%. THE PT WAS DISCHARGED 5 DAYS POST INDEX PROCEDURE. THE PT WAS ASYMPTOMATIC AT THE 1-MONTH AND 6-MONTH FOLLOW UP.

    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 13236380

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening BETA BLOCKERS| STATINS| CLOPIDOGREL| HEPARIN| WARFARIN| ASPIRIN