BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2021814 · Received March 17, 2011

    Report

    Report Number
    9616099-2011-00188
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE HAS BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    WHEN THE CYPHER STENT WAS REMOVED FROM THE PACKAGING IT WAS NOTICED THAT BOTH ENDS OF THE STENT WERE ALREADY SLIGHTLY EXPANDED AND PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGE OR BOX. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. NO EXCESSIVE FORCE WAS USED TO REMOVE THE DEVICE FROM THE PACKAGE. ONE NON-STERILE CYPHER SELECT + 3.50 X 8 MM WAS RECEIVED COILED IN TWO PLASTIC BAGS. THE STENT WAS OUT OF POSITION. THE BALLOON WAS INFLATED. RESIDUES OF INFLATION MEDIUM WERE OBSERVED. CRIMPING MARKS WERE OBSERVED. STRUT UPLIFT WAS NOTICED ON BOTH ENDS OF THE STENT. NO OTHER ANOMALIES WERE OBSERVED. DIMENSIONAL ANALYSIS WAS NOT PERFORMED SINCE THE STENT WAS DAMAGED. 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. THE REPORTED FAILURE WAS CONFIRMED. THE EXACT CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED AND IT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. IT APPEARS THAT THE BALLOON WAS INFLATED PARTIALLY AS EVIDENCED BY CONTRAST MEDIA RESIDUE FOUND AND PARTIAL EXPANSION OF STENT ON BOTH ENDS. NEITHER THE DHR NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE ISSUE IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO ACTION WAS TAKEN.

    Description of Event or Problem · 1

    WHEN THE CYPHER STENT WAS REMOVED FROM THE PACKAGING IT WAS NOTICED THAT BOTH ENDS OF THE STENT WERE ALREADY SLIGHTLY EXPANDED AND PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGE OR BOX. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. NO EXCESSIVE FORCE WAS USED TO REMOVE THE DEVICE FROM THE PACKAGE.

    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 15303616

    Patients

    Seq Age Sex Outcome Treatment
    1