BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 3883935 · Received June 13, 2014

    Report

    Report Number
    1820334-2014-00248
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION, A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) AND TRENDS WAS CONDUCTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. EVALUATION IS BASED ON THE DESCRIPTION AND THE IMAGES. THE EVENT IS DESCRIBED AS: "CANCER AND INFERIOR VENA CAVA THROMBUS BELOW THE RENAL VEINS. THE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER WAS DEPLOYED IN AN UNSATISFACTORY POSITION. THE FILTER WAS REPOSITIONED THREE TIMES AND ON THE THIRD TRY IT PREMATURELY DEPLOYED IN AN UNSATISFACTORY POSITION. A REMOVAL SET WAS USED TO REMOVE THE FILTER AND PUT IN ANOTHER ONE. THE SNARE ENGAGED THE FILTER AT THE CLIP BUSHING THAT HOLDS THE LEGS TOGETHER. THE PHYSICIAN COULD NOT GET IT TO DISENGAGE. UPON LOOKING AT THE FILMS, THE ANGLE AT WHICH THE FILTER WAS DEPLOYED VS THE ANGLE AT WHICH THE SNARE CAME THROUGH THE HEART INTO THE INFERIOR VENA CAVA WAS DIFFICULT AND IN THE OPINION OF THE DISTRICT MANAGER LED TO THE PREMATURE DEPLOYMENT AND THE SNARE GETTING CAUGHT. THE PHYSICIAN WORKED FOR A WHILE AND ENDED UP BREAKING THE SNARE AND LEAVING IT IN THE PATIENT ATTACHED TO THE FILTER. THE FILTER WAS DAMAGED, BUT STILL INTACT. THE PATIENT WAS REMOVED FROM THE TABLE WITH THE SNARE STILL ATTACHED TO THE FILTERS." THE RETURNED IMAGES WERE REVIEWED. SOME OF THE FINDINGS AND IMPRESSIONS ARE AS FOLLOWS: THE FINAL TWO IMAGING RUNS DEMONSTRATE THE FILTERS FINAL POSITION. IT IS NOW IN THE SUPRARENAL IVC AND DEMONSTRATES EVIDENCE OF TWISTING. THE FRACTURED SNARE LOOP IS STILL ATTACHED AND UNDERNEATH A BENT SECONDARY LEG. ALL THE LEGS ARE ACCOUNTED FOR. THE FILTER WAS FINALLY DEPLOYED IN A SUPRARENAL POSITION. THE SNARE WOULD NOT RELEASE BECAUSE IT WAS TRAPPED UNDER A BENT SECONDARY LEG. FORTUNATELY THE SNARE WAS FRACTURED SUCH THAT IT DID NOT EXTEND INTO THE IVC. FILTER TILT WAS IN PART DUE TO THE IVC CURVATURE BUT ALSO DEPLOYMENT OF THE FILTER ACROSS RATHER THAN BELOW THE RENAL VEINS SUCH THAT AT LEAST TWO SECONDARY LEGS PROLAPSED WITH RESPIRATORY MOTION INTO THE RIGHT RENAL VEIN. THE FILTER TILT, HOOK DIRECTION, AND IVC CURVATURE ALL FACILITATED RATHER THAN HINDERED HOOK RELEASE. THE FILTER AND SNARE FRAGMENT ARE STILL RETRIEVABLE IF THIS BECOMES CLINICALLY INDICATED. THE EXACT ROOT CAUSE ON WHY THE SNARE GOT TRAPPED UNDER A BENT SECONDARY LEG FOLLOWING FRACTURE ARE UNKNOWN. HOWEVER, THE FRACTURE IS MOST LIKELY DUE TO EXCESSIVE FORCE APPLIED TO THE PRODUCT WHEN ATTEMPTING TO RETRACT THE INTRODUCER. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT LABELED. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE FILTER WAS DEPLOYED IN AN UNSATISFACTORY POSITION. THE FILTER WAS REPOSITIONED THREE TIMES AND ON THE THIRD TRY IT PREMATURELY DEPLOYED IN AN UNSATISFACTORY POSITION. A REMOVAL SET WAS USED TO REMOVE THE FILTER AND PUT IN ANOTHER ONE. THE SNARE ENGAGED THE FILTER AT THE CLIP BUSHING THAT HOLDS THE LEGS TOGETHER. THE PHYSICIAN COULD NOT GET IT TO DISENGAGE. UPON LOOKING AT THE FILMS, THE ANGLE AT WHICH THE FILTER WAS DEPLOYED VS. THE ANGLE AT WHICH THE SNARE CAME THROUGH THE HEART INTO THE INFERIOR VENA CAVA WAS DIFFICULT AND IN THE OPINION OF THE DISTRICT MANAGER LED TO THE PREMATURE DEPLOYMENT AND THE SNARE GETTING CAUGHT. THE PHYSICIAN WORKED FOR A WHILE AND ENDED UP BREAKING THE SNARE AND LEAVING IT IN THE PATIENT ATTACHED TO THE FILTER. THE FILTER WAS DAMAGED, BUT STILL INTACT. THE PATIENT WAS REMOVED FROM THE TABLE WITH THE SNARE STILL ATTACHED TO THE FILTERS. THE DEVICE REMAINS IN THE PATIENT ATTACHED TO THE SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351028 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other