BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FILTER

    MDR report key: 9588304 · Received January 14, 2020

    Report

    Report Number
    2020394-2020-00237
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Report Date
    July 21, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE MALFUNCTIONS WERE NOT PROVIDED AND A LOT HISTORY REVIEW COULD NOT BE PERFORMED. THE DEVICES WERE NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR PERFORATION OF THE IVC, OCCLUSION, UNINTENDED MOVEMENT AND RETRIEVAL DIFFICULTIES AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. STAVROPOULOS, S. W., SING, R. F., ELMASRI, F., SILVER, M. J., POWELL, A., ET ALL. (2014). THE DENALI TRIAL: AN INTERIM ANALYSIS OF A PROSPECTIVE, MULTICENTER STUDY OF THE DENALI RETRIEVABLE INFERIOR VENA CAVA FILTER. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 25(10):1497-505. DOI: 10.1016/J.JVIR.2014.07.001 H10: (CONCLUSION). 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.

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE MALFUNCTION WAS NOT PROVIDED AND A LOT HISTORY REVIEW WAS NOT PERFORMED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR PERFORATION OF THE IVC, OCCLUSION, UNINTENDED MOVEMENT AND RETRIEVAL DIFFICULTIES AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. H10: G4, H6(DEVICE: 4001). H11: B5, G1. 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 TEN MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNK DENALI VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE, UNINTENDED MOVEMENT, OBSTRUCTION AND PERFORATION OF THE IVC. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENTS WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNKNOWN DENALI VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE, UNINTENDED MOVEMENT, OBSTRUCTION AND PERFORATION OF THE IVC. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE MALFUNCTION WAS NOT PROVIDED AND A LOT HISTORY REVIEW WAS NOT PERFORMED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR DIFFICULT TO REMOVE, UNINTENDED MOVEMENT AND OBSTRUCTION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNKNOWN DENALI VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE, UNINTENDED MOVEMENT AND OBSTRUCTION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49987 DENALI FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown