BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA CAVA FILTER SYSTEM

    MDR report key: 5160415 · Received October 20, 2015

    Report

    Report Number
    2020394-2015-01724
    Event Type
    Injury
    Date Received
    October 20, 2015
    Report Date
    September 22, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER COULD NOT BE PROVIDED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES WERE ABLE TO BE PROVIDED TO THE MANUFACTURER. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED EVENT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. LABELING REVIEW: PRODUCT NAME OF THE DEVICE WAS UNKNOWN; HOWEVER, INITIAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER STATED IT MAY BE RECOVERY OR G2. RECOVERY FILTER (RF048F): THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN REPORTS FOR EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. MOST CASES OF THE FILTER FRACTURE, HOWEVER, HAVE BEEN REPORTED WITHOUT ANY ADVERSE CLINICAL SEQUELAE. PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNKNOWN PERIOD OF TIME, POST VENA CAVA FILTER DEPLOYMENT, ANTERIOR FILTER LIMB(S) LOCATED ADJACENT TO THE DUODENUM WERE DISCOVERED TO HAVE DETACHED AND WERE UNABLE TO BE VISUALIZED ON CT IMAGING. PER THE HEALTHCARE PROFESSIONAL, THE FILTER LIMB(S) PRESUMABLY PENETRATED THE DUODENUM AND WERE EXCRETED THROUGH THE PATIENTS GI SYSTEM. IMPACT TO PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692403 VENA CAVA FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other