BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 18299239 · Received December 11, 2023

    Report

    Report Number
    2020394-2023-01216
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    May 9, 2017
    Report Date
    August 13, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040801
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIRM RECEIVED AN FDA EMAIL CORRESPONDENCE ON (B)(6) 2024 FROM MDR DATA SYSTEMS TEAM, (B)(6) INDICATING THAT THE INFORMATION (SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D) OF THE PREVIOUSLY SUBMITTED FDA FORM 3500A, WAS INCORRECT AND A REQUEST WAS MADE TO SUBMIT SUPPLEMENTAL REPORT(S) WITH THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS IN THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELDS. THIS SUPPLEMENTAL REPORT IS IN RESPONSE TO THAT REQUEST. UDI RELATED DATA QUALITY UPDATES ONLY. D4: MEDICAL DEVICE EXPIRATION DATE- 12/31/2025. D4: UDI- (B)(4). G4: K240257, K160866, K143208, K130366.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY THREE YEARS AND SEVEN MONTHS POST FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY OF ABDOMEN WAS PERFORMED FOR INFERIOR VENA CAVA FILTER CHECK AND LEFT LEG, AND HIP PAIN. THE STUDY SHOWED INFERIOR VENA CAVA FILTER WAS PROPERLY POSITIONED BELOW THE RENAL VEINS. THE FILTER WAS TILTED ANTERIORLY WITH ITS CONE LYING ON THE POSTERIOR WALL OF THE INFERIOR VENA CAVA. THE LEGS OF THE FILTER HAVE PENETRATED THROUGH THE WALL OF THE INFERIOR VENA CAVA INTO THE PERICAVAL/MESENTERIC FAT. ONE OF THE LEGS IS IN CONTACT WITH THE ANTERIOR PERIOSTEUM OF A LUMBAR VERTEBRA WITH CHRONIC REACTIVE CHANGES WHICH MAY INDICATE THAT IT IS POSSIBLY EMBEDDED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION OF VENA CAVA WALL, FILTER TILT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: D4 (EXPIRATION DATE: 05/2015). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED VIA RIGHT COMMON FEMORAL VEIN APPROACH FOR A PATIENT WITH HIGH RISK FOR DEEP VEIN THROMBOSIS AND UNABLE TO ANTI-COAGULATE SECONDARY TO INTRACRANIAL BLEEDING. IT WAS FURTHER REPORTED THAT THREE YEARS, SIX MONTHS AND TWENTY-SIX DAYS POST FILTER DEPLOYMENT, THE FILTER WAS ALLEGEDLY TILTED ANTERIORLY WITH ITS CONE LYING ON THE POSTERIOR WALL OF THE INFERIOR VENA CAVA. FURTHERMORE, THE FILTER STRUTS HAD ALLEGEDLY PERFORATED THE INFERIOR VENA CAVA INTO THE PERICAVAL/MESENTERIC FAT AND ONE OF THE LEGS WAS IN CONTACT WITH THE ANTERIOR PERIOSTEUM OF A LUMBAR VERTEBRA. REPORTEDLY, THE PATIENT ALLEGEDLY EXPERIENCED HIP PAIN. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED VIA RIGHT COMMON FEMORAL VEIN APPROACH FOR A PATIENT WITH HIGH RISK FOR DEEP VEIN THROMBOSIS AND UNABLE TO ANTI-COAGULATE SECONDARY TO INTRACRANIAL BLEEDING. IT WAS FURTHER REPORTED THAT THREE YEARS, SIX MONTHS AND TWENTY-SIX DAYS POST FILTER DEPLOYMENT, THE FILTER WAS ALLEGEDLY TILTED ANTERIORLY WITH ITS CONE LYING ON THE POSTERIOR WALL OF THE INFERIOR VENA CAVA. FURTHERMORE, THE FILTER STRUTS HAD ALLEGEDLY PERFORATED THE INFERIOR VENA CAVA INTO THE PERICAVAL/MESENTERIC FAT AND ONE OF THE LEGS WAS IN CONTACT WITH THE ANTERIOR PERIOSTEUM OF A LUMBAR VERTEBRA. REPORTEDLY, THE PATIENT ALLEGEDLY EXPERIENCED HIP PAIN. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137866 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFXD3014 00801741040801

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other