BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRUX VENA CAVA FILTER SYSTEM - FEMORAL

    MDR report key: 3675296 · Received February 28, 2014

    Report

    Report Number
    2939520-2014-00015
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    CRUX BIOMEDICAL, INC.
    Product Code
    DTK
    PMA / PMN Number
    K122585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT IS FROM THE (B)(4) AND WAS ENROLLED ON (B)(6) /2011. THE DEVICE WAS MANUFACTURED BY CRUX BIOMEDICAL, INC AS PART OF THIS STUDY. VOLCANO CORP BOUGHT CRUX BIOMEDICAL IN (B)(4) AND THE COMPANY NO LONGER EXISTS; THEREFORE, VOLCANO CORP IS REPORTING THIS INCIDENT TO THE FDA. THE PHYSICIAN STATED THAT HE WILL BE FOLLOWING UP WITH THE PATIENT IN ABOUT ONE MONTH AND MAY HAVE A CT SCAN DONE AT THAT TIME. THERE WAS NO SURGICAL INTERVENTION PERFORMED. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO VOLCANO, SO A DEVICE EVALUATION HAS NOT BEEN PERFORMED YET. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PRE-RETRIEVAL PROCEDURE ABDOMINAL X-RAY COMPLETED WHICH REVEALED A "KINK" IN THE CAUDAL LOOP OF THE FILTER JUST INFERIOR TO THE CROSSOVER. VENOUS ACCESS WAS ACCOMPLISHED VIA THE RIGHT FEMORAL VEIN. THE CAUDAL RETRIEVAL TAIL WAS VISIBLE AND SNARED. UPON RE-SHEATHING THE REMAINDER OF THE FILTER FOR RETRIEVAL, THE FILTER FRAME AND POSSIBLY A TISSUE ANCHOR SEPARATED AND ONLY THE CAUDAL LOOP WAS RETRIEVED INTO THE SHEATH, LEAVING THE CRANIAL LOOP IN SITU. A SECOND VENOUS ACCESS WAS OBTAINED VIA THE RIGHT INTERNAL JUGULAR VEIN AND THE RETRIEVAL TAIL WAS VISIBLE AND SNARED. THE REMAINDER OF THE CRANIAL LOOP WAS RE-SHEATHED BUT A PORTION OF THE WIRE FRAME WITH POSSIBLY A TISSUE ANCHOR APPEARED TO REMAIN IN SITU. THE PHYSICIAN STATED THAT THE SEPARATION OCCURRED AT THE UPPER MOST TISSUE ANCHOR OF THE CAUDAL LOOP. THE PHYSICIAN STATED THAT HE INSPECTED THE PORTIONS OF THE CRUX VCF THAT WAS REMOVED AND FEELS THAT THE EPTFE WEB IS INTACT AND DID NOT EMBOLIZE. HE RETAINED THE CRUX VCF ALONG WITH IMAGES FROM THE PROCEDURE TO RETURN TO VOLCANO FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124880 CRUX VENA CAVA FILTER SYSTEM - FEMORAL CARDIOVASCULAR FILTER DTK CRUX BIOMEDICAL, INC. 7014 121610C01-15

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening