BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1834040 · Received September 14, 2010

    Report

    Report Number
    3003742446-2010-00322
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    February 12, 2010
    Report Date
    August 19, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. CORONARY ARTERY DISSECTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION CHARACTERISTICS (OSTIAL AND HEAVILY CALCIFIED) AND/OR PROCEDURAL FACTORS (MULTIPLE PRE-DILATIONS) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NOT CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B)(4) STUDY. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, PERIPHERAL VASCULAR DISEASE, OBESITY, MYOCARDIAL INFARCTIONS, PREVIOUS CARDIAC INTERVENTION, AND A FAMILY HISTORY OF CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE OSTIAL TO MID RCA. PRE-PROCEDURE STENOSIS WAS 95% AND LESION LENGTH WAS 27MM. THE LESION WAS PRE-DILATED. A CYPHER 3.5 X 28MM STENT WAS ATTEMPTED BUT COULD NOT CROSS THE LESION. THE LESION WAS DILATED AGAIN AND THE STENT STILL COULD NOT CROSS THE LESION. THE STENT WAS EXCHANGED FOR A 3.5 X 13MM CYPHER STENT. THE 2ND CYPHER WAS ATTEMPTED AND COULD NOT CROSS THE LESION. THE LESION WAS DILATED AGAIN AND THE STENT WAS ATTEMPTED 2 MORE TIMES. AN ABBOT XIENCE STENT WAS USED TO TREAT THE LESION. POST-DILATION WAS CONDUCTED AND THE 3.5 X 13 CYPHER WAS ATTEMPTED AGAIN. PER THE STUDY COORDINATOR, A DISSECTION OCCURRED IN THE OSTIAL RCA DURING THE ATTEMPT TO CROSS THE 3.5 X 13 CYPHER. AN ABBOTT XIENCE 3.5 X 18MM STENT WAS USED TO TREAT THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15071791

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention ANGIOMAX, ASPIRIN, CLOPIDDOGREL