BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053322 · Received May 22, 2008

    Report

    Report Number
    9616099-2008-01373
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    November 20, 2007
    Report Date
    April 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 MANUFACTURER REPORT NUMBER IS 9616099-2008-01372. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY 8 MONTHS POST-PROCEDURE, THE PATIENT WAS ADMITTED WITH WORSENING EXERTIONAL CHEST PAIN. AN ANGIOGRAPHY AND RE-PCI WAS CONDUCTED. AN 80% STENOSIS IN THE DISTAL LAD WAS TREATED WITH A TAXUS STENT. THE INDEX CYPHERS HAD 80-90% FOCAL RESTENOSIS. THESE STENTS WERE TREATED WITH A CUTTING BALLOON AT 14 ATM. NO NEW STENT DEPLOYMENT WAS NEEDED. THE REPORT IS FROM THE STUDY. THE PATIENT WAS A MALE WITH 2-VESSEL DISEASE AND A HISTORY OF OBESITY, HYPERTENSION, HYPERLIPIDEMIA, AND SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 40MM. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS DE NOVO, BIFURCATED, IRREGULAR CONTOUR, AND MODERATELY ANGLED. LESION LOCATION ACCORDING TO MEDINA WAS 1,0,0. THE LESION WAS PRE-DILATED WITH A 2 X 20MM BALLOON AT 12 ATM. TWO STENTS WERE IMPLANTED, OVERLAPPING, IN THIS LESION. A CYPER WAS DEPLOYED AT 16 ATM AND POST-DILATED BECAUSE THE STENT WAS NOT FULLY EXPANDED. ANOTHER CYPHER WAS DEPLOYED AT 14 ATM AND POST-DILATED BECAUSE IT WAS NOT FULLY EXPANDED. POST-PROCEDURE STENOSIS WAS 0%. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT 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 13176725

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention STATINS| HEPARIN| MEDICATIONS: ACE INHIBITORS| CLOPIDOGREL| ASPIRIN| INTEGRILIN