BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 2211637 · Received August 15, 2011

    Report

    Report Number
    9616099-2011-00643
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 14, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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

    THE STENT STRUT OF THE PALMAZ GENESIS WAS PROTRUDING UPON REMOVAL FROM PACKAGE. THE ACCOUNT REPORTS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE AND NO EXCESSIVE FORCE WAS USED. 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. REVIEW OF LOT 15207561 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15207561. SDS-ASSY SUBASSEMBLY LOT 15206966 WAS REVIEWED AND NO UNITS WERE REJECTED DURING THE ASSEMBLY OF THIS LOT. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. THE STENT CRIMPED PROCESS WAS REVIEWED AND THE STENT CROSSING PROFILE AND STENT RETENTION TESTS WERE ACCEPTED ACCORDING TO SPECIFICATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THIS MIGHT HAVE BEEN CAUSED DURING PACKAGING, SHIPPING, STORAGE, OR HANDLING OF THE UNIT.

    Description of Event or Problem · 1

    THE STENT STRUT OF THE PALMAZ GENESIS WAS PROTRUDING UPON REMOVAL FROM PACKAGE. A SECOND STENT WAS USED NO ISSUES. THE ACCOUNT REPORTS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE AND NO EXCESSIVE FORCE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15207561

    Patients

    Seq Age Sex Outcome Treatment
    1