BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1996474 · Received February 18, 2011

    Report

    Report Number
    9616099-2011-00110
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN HAD DIFFICULTY ADVANCING THE CYPHER SELECT PLUS 3.0 X 33 MM STENT THROUGH THE CO-PILOT Y-CONNECTOR AND THE DEVICE BECAME STUCK/IMPEDED. THE PHYSICIAN REMOVED THE PRODUCT FROM THE PATIENT AND UPON INSPECTION THE PROXIMAL STENT STRUTS WERE NOTED TO BE FLARED/UPLIFTED. ANOTHER CYPHER SELECT PLUS STENT OF THE SAME CATALOG/LOT NUMBER WAS USED WITH THE SAME CO-PILOT CONNECTOR AND RESISTANCE WAS ALSO EXPERIENCED. THEREFORE, THE PHYSICIAN EXCHANGED THE CO-PILOT TO A NEW SET AND THE CYPHER STENT WAS DELIVERED WITHOUT DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE CYPHER SELECT + 3.00X33 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE Y CONNECTOR USED DURING THE PROCEDURE WAS NOT RETURNED. THE UNIT WAS RECEIVED WAVY; THIS CONDITION COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR ANALYSIS. STENT WAS FOUND MOUNTED AND ITS ORIGINAL PLACE BETWEEN THE MARKER BANDS. NO OTHER DAMAGES WERE FOUND. THE CROSSING PROFILE WAS MEASURED FOR MIDDLE AND PROXIMAL SECTIONS OF THE STENT AND WAS FOUND WITHIN SPECIFICATION. THE DISTAL SECTION WAS NOT MEASURE SINCE IT WAS DAMAGED. THE UNIT WAS INSERTED IN A ''Y'' CONNECTOR AND NO RESISTANCE WAS FELT. 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 STENT DELIVERY SYSTEM (SDS)/ IMPEDED REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE RESISTANCE WAS NOT FELT WHEN THE UNIT WAS INSERTED IN A Y CONNECTOR. STENT/ STRUT UPLIFT-DURING USE WAS CONFIRMED. THE CAUSE OF THE FAILURES EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THESE FAILURES. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED ISSUE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WAS TAKEN.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN HAD DIFFICULTY ADVANCING THE CYPHER SELECT PLUS 3.0 X 33 MM STENT THROUGH THE CO-PILOT Y-CONNECTOR AND THE DEVICE BECAME STUCK/IMPEDED. THE PHYSICIAN REMOVED THE PRODUCT FROM THE PATIENT AND UPON INSPECTION THE STENT STRUTS WERE NOTED TO BE FLARED/UPLIFTED. ANOTHER CYPHER SELECT PLUS STENT OF THE SAME CATALOG/LOT NUMBER WAS USED WITH THE SAME CO-PILOT CONNECTOR TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 15285878

    Patients

    Seq Age Sex Outcome Treatment
    1