BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMON NITINOL FILTER SYSTEM

    MDR report key: 9214203 · Received October 21, 2019

    Report

    Report Number
    2020394-2019-04121
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    April 8, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OF THE SIX REPORTED MALFUNCTIONS, 1 MALFUNCTION WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WAS REPORTED UNDER EMDR 2020394-2021-80153. OF THE REMAINING FIVE MALFUNCTIONS, THE LOT NUMBER WAS NOT PROVIDED FOR ALL MALFUNCTIONS AND LOT HISTORY REVIEWS COULD NOT BE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE RECEIVED AND REVIEWED FOR FIVE MALFUNCTIONS. FOR FOUR MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR BOTH TILT AND PERFORATION OF THE IVC. FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR TILT BUT IS INCONCLUSIVE FOR PERFORATION OF THE IVC. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. 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: OF THE SIX REPORTED MALFUNCTIONS, 1 WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WILL BE REPORTED UNDER EMDR. H10: OF THE REMAINING FIVE MALFUNCTIONS, THE LOT NUMBER WAS NOT PROVIDED FOR ALL MALFUNCTIONS AND LOT HISTORY REVIEWS COULD NOT BE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE RECEIVED AND REVIEWED FOR FIVE MALFUNCTIONS. FOR FOUR MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR BOTH TILT AND PERFORATION OF THE IVC. FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR TILT BUT IS INCONCLUSIVE FOR PERFORATION OF THE IVC. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. H10: G4 H11: B5, D4(CORPORATE LOT NO), 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 FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND PERFORATION OF THE IVC. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL FIVE MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. FIVE PATIENTS¿ AGE RANGED FROM 41-69 YEARS OF AGE. TWO PATIENTS¿ WEIGHTS RANGED FROM 253-309 LBS. OF THE REPORTED PATIENTS, FOUR WERE MALE AND ONE WAS FEMALE. ALL REMAINING PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND PERFORATION OF THE IVC. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL FIVE MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. FIVE PATIENTS¿ AGE RANGED FROM 41-69 YEARS OF AGE. TWO PATIENTS¿ WEIGHTS RANGED FROM 253-309 LBS. OF THE REPORTED PATIENTS, FOUR WERE MALE AND ONE WAS FEMALE. ALL REMAINING PATIENT INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR ONE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED, ALL OTHER LOT NUMBERS ARE UNKNOWN. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE RECEIVED AND REVIEWED FOR FOUR MALFUNCTIONS. FOR THREE MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR BOTH TILT AND PERFORATION OF THE IVC. FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR TILT BUT IS INCONCLUSIVE FOR PERFORATION OF THE IVC. THE TWO REMAINING MALFUNCTIONS THAT DID NOT HAVE MEDICAL RECORDS PROVIDED ARE INCONCLUSIVE FOR TILT AND PERFORATION OF THE IVC. 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 SIX MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND PERFORATION OF THE IVC. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL SIX MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. FOUR PATIENTS¿ AGE RANGED FROM 41-69 YEARS OF AGE. TWO PATIENTS¿ WEIGHTS RANGED FROM 253-309 LBS. OF THE REPORTED PATIENTS, THREE WERE MALE AND ONE WAS FEMALE. ALL REMAINING PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007513 SIMON NITINOL FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. 2120F UNKNOWN 00801741040900

    Patients

    Seq Age Sex Outcome Treatment
    1