BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    466P306X

    MDR report key: 8013930 · Received October 29, 2018

    Report

    Report Number
    9616099-2018-02469
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    August 14, 2018
    Report Date
    May 29, 2019
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO PRODUCT CODE.

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS AN UNKNOWN FILTER AND THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. KOIZUMI, J., HARA, T., SEKIGUCHI, T., ICHIKAWA, T., TAJIMA, H., TAKENOSHITA, N., SHIRATO, K. (2018). MULTICENTER INVESTIGATION OF THE INCIDENCE OF INFERIOR VENA CAVA FILTER FRACTURE. JAPANESE JOURNAL OF RADIOLOGY, 36(11), 661-668. DOI:10.1007/S11604-018-0764- AS NOTED IN THE PUBLICATION BY KOIZUMI ET AL., MULTICENTER INVESTIGATION OF THE INCIDENCE OF INFERIOR VENA CAVA FILTER FRACTURE; JPN J RADIOL. 2018 AUG 14. DOI: 10.1007/S11604-018-0764-X; THERE WAS ONE CASE OF A TRAPEASE FILTER FRACTURE ONE-THOUSAND, EIGHT-HUNDRED AND NINETY-EIGHT DAYS POST IMPLANTATION. A COMPUTERIZED TOMOGRAPHY (CT) IMAGE REVEALED THE FRACTURED STRUT IS LOCATED IN THE LOWER UMBRELLA AND A FRAGMENT IS LOCATED NEAR THE CARDIAC APEX. THE CT IMAGE ALSO REVEALED A FRAGMENT IN THE PERICARDIAL FAT PAD BEYOND THE RIGHT VENTRICLE WITHOUT CARDIAC TAMPONADE. THE FILTER WAS IMPLANTED IN THE SUPRARENAL POSITION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE STERILE LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. WITHOUT PROCEDURAL FILMS AVAILABLE FOR REVIEW, THE REPORTED ¿FILTER- FRACTURED-SEPARATED - IN PATIENT¿ AND ¿FILTER- MIGRATION¿ COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) STATES FILTER FRACTURE IS A POTENTIAL COMPLICATION OF VENA CAVA FILTERS. ANATOMIC LOCATIONS THAT CREATE CONCENTRATED STRESS POINTS FROM FILTER DEFORMATION (FOR EXAMPLE, DEPLOYMENT AT APEX OF SCOLIOSIS, OVERLAPPING OF EITHER OF THE RENAL OSTIA, OR PLACEMENT ADJACENT TO A VERTEBRAL OSTEOPHYTE) MAY CONTRIBUTE TO FRACTURE OF A PARTICULAR FILTER STRUT. INFERIOR VENA CAVA (IVC) FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE INSTRUCTION FOR USE (IFU) AS SUCH. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDES MEGA CAVA, WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, ¿SAIL¿ EFFECT (CRANIAL MIGRATION) OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. PHYSIOLOGIC CAUSES OF MIGRATION MAY RESULT FROM TEMPORARY DYSMORPHISM OF THE INFERIOR VENA CAVA INCLUDING BENDING, COUGHING OR VALSALVA MANEUVERS RESULTING IN DISLODGMENT OF THE FILTER. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO MIGRATION OF IVC FILTERS. GIVING THE LIMITED INFORMATION AVAILABLE AT THIS TIME, CLINICAL FACTOR CONTRIBUTING TO THE MIGRATION COULD NOT BE DETERMINED. ALSO, WITH THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND/OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY KOIZUMI ET AL., MULTICENTER INVESTIGATION OF THE INCIDENCE OF INFERIOR VENA CAVA FILTER FRACTURE; JPN J RADIOL. 2018 AUG 14. DOI: 10.1007/S11604-018-0764-X; THERE WAS ONE CASE OF A TRAPEASE FILTER FRACTURE ONE-THOUSAND, EIGHT-HUNDRED AND NINETY-EIGHT DAYS POST IMPLANTATION. A COMPUTERIZED TOMOGRAPHY (CT) IMAGE REVEALED THE FRACTURED STRUT IS LOCATED IN THE LOWER UMBRELLA AND A FRAGMENT IS LOCATED NEAR THE CARDIAC APEX. THE CT IMAGE ALSO REVEALED A FRAGMENT IN THE PERICARDIAL FAT PAD BEYOND THE RIGHT VENTRICLE WITHOUT CARDIAC TAMPONADE. THE FILTER WAS IMPLANTED IN THE SUPRARENAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854464 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR