BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1830078 · Received September 10, 2010

    Report

    Report Number
    3003742446-2010-00319
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 12, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM A SALES REPRESENTATIVE INDICATED THAT A STENT DISLODGED AND WAS INACCURATELY PLACED AFTER THE STENT FAILED TO CROSS THE LESION. THE LESION WAS IN THE RIGHT CORONARY ARTERY IN THE AREA OF A BIFURCATION BETWEEN THE POSTERO-LATERAL BRANCH (PL) AND THE POSTERIOR-DESCENDING BRANCH (PDA). A CYPHER STENT WAS IMPLANTED IN THE PDA FOLLOWED THE DELIVERY OF A 2.5MM X 13MM CYPHER STENT. THE STENT BECAME HUNG UP ON THE PREVIOUSLY IMPLANTED STENT AND WHILE PULLING THE STENT DELIVERY SYSTEM BACK, THE STENT CAME OFF THE BALLOON. THE STENT WAS SUBSEQUENTLY CRUSHED IN DISEASED AREA, WITH A 3.0 X 18MM CYPHER STENT, AND POST-DILATED WITH A 3.5 X 15MM DURASTAR BALLOON CATHETER. THE PATIENT WAS IN STABLE CONDITION. 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. STENT DISLODGEMENT IS A KNOWN POTENTIAL PROCEDURAL COMPLICATION ASSOCIATE WITH IMPLANTING CORONARY ARTERY STENTS. STENTING IN THE AREA OF A BIFURCATION CAN BE MORE DIFFICULT THAN STENTING IN THE MAIN PORTION OF THE VESSEL AND IS DEPENDENT ON VESSEL/LESION CHARACTERISTICS AND PRACTITIONER EXPERIENCE. REVIEW OF THE LIMITED INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE INFORMATION PROVIDED OR THE DHR REVIEW TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A 2.5 X 10MM DURASTAR BALLOON CATHETER WAS USED DURING THE INDEX PROCEDURE. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED WITH A LESION IN THE RIGHT CORONARY ARTERY. A 2.5 X 13MM CYPHER STENT DELIVERED TO THE LESION, HOWEVER, THE STENT STRUTS BECAME HUNG UP ON THE CYPHER STENT THAT HAD PREVIOUSLY BEEN IMPLANTED, DURING THE SAME SETTING. WHILE PULLING THE STENT DELIVERY SYSTEM BACK, THE STENT CAME OFF OF THE BALLOON. THE STENT WAS SUBSEQUENTLY CRUSHED IN DISEASED AREA, WITH A 3.0 X 18MM CYPHER STENT, AND POST-DILATED WITH A 3.5 X 15MM DURASTAR BALLOON CATHETER. THE PATIENT WAS IN STABLE CONDITION.

    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 15104819

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention