BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 9955757 · Received April 13, 2020

    Report

    Report Number
    9681442-2020-00111
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Report Date
    June 19, 2020
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    00801741144974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED; THEREFORE, A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE WAS RETURNED FOR THE EVALUATION. ONE PHOTO WAS ALSO PROVIDED FOR REVIEW. THE INVESTIGATING CONFIRMED FOR PARTIAL DEPLOYMENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE IS LABELED FOR SINGLE USE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FVL06080 VASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE 56 YEAR OLD FEMALE WAS 72 KGS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED; THEREFORE, A LOT HISTORY REVIEW WILL BE PERFORMED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ONE PHOTO WAS ALSO PROVIDED FOR REVIEW. THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICE IS LABELED FOR SINGLE USE. THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE FLUENCY PLUS VASCULAR STENT GRAFT PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE FOR THE FLUENCY PLUS VASCULAR STENT GRAFT PRODUCTS IS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FVL06080 VASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE (B)(6) YEAR OLD FEMALE WAS (B)(6) KGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417288 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANCP1432 00801741144974

    Patients

    Seq Age Sex Outcome Treatment
    1