BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032311 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01044
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    December 28, 2007
    Report Date
    March 26, 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 US. 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 9616099-2008-01043. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROX SIX MONTHS POST-PROCEDURE, THE PT RETURNED TO THE HOSP WITH ANGINA. ANGIOGRAPHY SHOWED THERE WAS 15% STENOSIS IN BOTH INDEX CYPHERS. THE FIRST STENT HAD DISTAL PERI-STENT RESTENOSIS AND THE SECOND STENT HAD PROXIMAL PERI-STENT RESTENOSIS. A 60% STENOSIS IN THE MID LAD WAS TREATED WITH A TAXUS STENT. POST-PROCEDURE, THERE WAS 10% STENOSIS. A MONTH FOLLOWING THIS PROCEDURE, THE PT WAS EXPERIENCING ANGINA AGAIN. THE REPORT IS FROM THE STUDY. THE PT WAS A MALE WITH A HISTORY OF OBESITY, SMOKING, AND DIABETES. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. THE FIRST TARGET LESION WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). VESSEL DIAMETER WAS 2.9MM AND THE LESION LENGTH WAS 5MM. PRE-PROCEDURE STENOSIS WAS 95%. THE LESION WAS DE NOVO AND A TYPE A CLASSIFICATION. THE LESION WAS NOT PRE-DILATED. THE FIRST STENT WAS DEPLOYED AT 16 ATMS. POST-PROCEDURE STENOSIS WAS 10%. TIMI FLOW WAS 3, PRE AND POST PROCEDURE. THE SECOND TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 10MM. PRE-PROCEDURE STENOSIS WAS 95%. THE LESION WAS DE NOVO AND A TYPE A CLASSIFICATION. THE LESION WAS NOT PRE-DILATED. THE SECOND STENT WAS DEPLOYED AT 16 ATMS. THE STENTS WERE NOT OVERLAPPING. POST-PROCEDURE STENOSIS WAS 10%. THE PT WAS DISCHARGED THE FOLLOWING DAY.

    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 13204565

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CLOPIDOGREL| STATINS| HEPARIN| MEDICATIONS: ASPIRIN| BETA BLOCKERS