BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 9955641 · Received April 13, 2020

    Report

    Report Number
    9681442-2020-00106
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Report Date
    June 22, 2020
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    00801741145247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NO FOR THE DEVICE WAS PROVIDED, THEREFORE A LOT HISTORY REVIEW WAS PERFORMED.THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER TWO IMAGES OF THE REPORTED MALFUNCTION WAS RECEIVED. BASED ON THE IMAGES RECEIVED,THE INVESTIGATION IS CONFIRMED FOR PARTIAL DEPLOYMENT OF STENT GRAFT. A DEFINITE ROOT CAUSE FOR THE REPORTED MALFUNCTION COULD NOT BE DETERMINED. THE DEVICE IS LABELED FOR SINGLE USE. H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 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 IN D2. 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 FVL10100 VASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE, FRACTURE, AND DIFFICULTY TO REMOVE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT WAS REPORTED AS A 78-YEAR-OLD MALE WHOSE WEIGHT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE FOR THE MALFUNCTION HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER TWO IMAGES OF THE REPORTED MALFUNCTION WAS RECEIVED. THE INVESTIGATION OF THE REPORTED MALFUNCTION IS CURRENTLY UNDERWAY. THE DEVICES ARE 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 FVL10100 VASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE, FRACTURE, AND DIFFICULTY TO REMOVE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT WAS REPORTED AS A (B)(6) YEAR-OLD MALE WHOSE WEIGHT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418786 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANDW1386 00801741145247

    Patients

    Seq Age Sex Outcome Treatment
    1