BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 3964131 · Received July 11, 2014

    Report

    Report Number
    1820334-2014-00312
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    August 20, 2012
    Report Date
    May 30, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: EVALUATION IS BASED ON EVENT DESCRIPTION ONLY, SINCE NO DEVICE, MED RECORDS OR IMAGING HAVE BEEN MADE AVAILABLE TO ASSIST IN THE INVESTIGATION. THE FILTER WAS IMPLANTED ON (B)(6) 2011. (B)(4) DEVICES WERE PRODUCED ON THE DEVICE LOT AND NO OTHER COMPLAINTS ON THE SAME LOT HAVE BEEN RECEIVED. THERE WERE NO RELEVANT NOTES ON THE WORK ORDER, NOR ON THE FILTER LOTS. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. THE DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE WHICH STATES, "EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILTER." THE EVALUATION IS BASED ON EVENT DESCRIPTION ONLY, SINCE NO DEVICE, MED RECORDS OR IMAGING HAS BEEN RETURNED. TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. DIFFICULT FILTER REMOVAL DUE TO THE EMBEDMENT OF FILTER LEGS IN THE IVC WALL IS WELL-KNOWN RISK THAT HAS BEEN DOCUMENTED IN THE SCIENTIFIC AND MED LITERATURE. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES DESCRIBE DIFFICULT FILTER REMOVAL FROM THE VENA CAVA WALL (WILLIAM T. KUO, ET AL: PHOTOTHERMAL ABLATION WITH THE EXCIMER LASER SHEATH TECHNIQUE FOR EMBEDDED INFERIOR VENA CAVA FILTER REMOVAL: INITIAL RESULTS FROM A PROSPECTIVE STUDY). WITHOUT IMAGES IT IS DIFFICULT TO COMMENT ON THE TOTAL OCCLUSION/SEVERE STENOSIS AT THE INFERIOR VENA CAVA AT THE LEVEL OF THE FEET OF THE FILTER. BASED ON THE ABOVE, THE EXACT REASON FOR THE DIFFICULT REMOVAL OF THE EMBEDDED FILTER REMAINS UNK. FURTHER RISK REDUCTION WILL NOT BE COMPLETED AT THIS TIME. THE MED BENEFIT OF PREVENTION OF RECURRENT PULMONARY EMBOLISMS OBTAINED BY PLACING AN IVC FILTER OUTWEIGHS THE RESIDUAL RISK OF THE DEVICE BEING DIFFICULT TO REMOVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. IT IS UNKNOWN IF THE REPORTED ¿QUESTIONABLE NON-OCCLUSIVE THROMBUS ASSOCIATED WITH THE LEFT RENAL VEIN VS. FLOW DEFECT" IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. IVC THROMBOTIC OCCLUSION AS AN OUTCOME FOR COOK IVC FILTERS IS ADDRESSED IN THE PUBLISHED SCIENTIFIC LITERATURE. IVC THROMBOTIC OCCLUSION IS DEFINED AS THE PRESENCE OF AN OCCLUDING THROMBUS IN THE IVC AFTER FILTER INSERTION AND DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY; THIS MAY BE SYMPTOMATIC OR ASYMPTOMATIC. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 08/03/2016 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED THE DEVICE IMPLANT ON (B)(6) 2011 VIA THE FEMORAL VEIN DUE TO PE AND DVT. AN UNSUCCESSFUL ATTEMPT TO RETRIEVE THE FILTER ALLEGEDLY OCCURRED ON (B)(6) 2012. THE PLAINTIFF ALLEGES THAT THE DEVICE IS UNABLE TO BE RETRIEVED AND PAIN.

    Description of Event or Problem · 1

    INFO FROM A LAW FIRM. THE ALLEGATIONS FO THE CLAIM IS: A (B)(6) FEMALE PT WITH A HISTORY OF DVT, P.E., LEUKOPENIA, AND HAS PAIN IN GROIN AT TIMES, UNDERWENT AN INFERIOR VENA CAVA FILTER REMOVAL, IT WAS NOTED THAT THE FILTER APPEARED TO BE CENTERED WELL IN THE INFERIOR VENA CAVA AND THERE DID NOT APPEAR TO BE ANY SIGNIFICANT RETAINED THROMBUS WITHIN THE FILTER. AT THIS POINT, IT WAS DECIDED TO PROCEED WITH RETRIEVAL OF THE FILTER. THE 5 FR SHEATH WAS UP-SIZED TO THE 11 FR FILTER DELIVERY SHEATH WHICH WAS ADVANCED OVER A WIRE INTO THE INFERIOR VENA CAVA. THE SNARE DEVICE WAS THEN DEPLOYED AND SUCCESSFULLY SNARED THE HOOK OF THE TULIP FILTER. ATTEMPTS WERE THEN MADE TO REMOVE THE FILTER. THE RETRIEVAL SHEATH WAS ADVANCED OVER THE FILTER TO COLLAPSE THE FILTER. THE FILTER PARTIALLY COLLAPSED; HOWEVER, THE LEGS COULD NEVER BE MADE TO FREE THEMSELVES FROM THE WALLS OF THE INFERIOR VENA CAVA DESPITE MULTIPLE ATTEMPTS. AT THIS POINT, IT WAS DETERMINED THAT FILTER RETRIEVAL WOULD NOT BE POSSIBLE. THE RETRIEVAL SHEATH WAS PULLED BACK AND THE SNARE DEVICE WAS REMOVED FROM THE FILTER. ADDITIONAL IMAGES OF THE INFERIOR VENA CAVA WERE PERFORMED, REVEALING APPARENT TOTAL OCCLUSION OF THE INFERIOR VENA CAVA AT THE LEVEL OF THE FILTER LEGS, NO DOUBT DUE TO RETRACTION OF THE WALLS OF THE INFERIOR VENA CAVA CENTRALLY BY THE FEET OF THE FILTER. AT THIS POINT, THE PT BEGAN TO BECOME HYPERTENSIVE, AND IT WAS DETERMINED TO PROCEED WITH BALLOON DILATATION OF THE INFERIOR VENA CAVA TO REEXPAND THE INFERIOR VENA CAVA. THE 11 FR RETRIEVAL SHEATH WAS REMOVED AND REPLACED WITH A SHORT 11 FR VASCULAR SHEATH. UTILIZING A GLIDE WIRE AND A STIFF ANGLED GLIDE CATHETER. SUCCESSFUL CROSS OF THE OCCLUSION OF THE INFERIOR VENA CAVA. REPEAT INFERIOR VENA CAVA IMAGES AT THIS POINT REVEALED A SEVERE STENOSIS AT THE INFERIOR VENA CAVA AT THE LEVEL OF THE FEET OF THE FILTER. THE INFERIOR VENA CAVA WAS THEN GENTLY DILATED INITIALLY WITH A 10 MM BALLOON AND SUBSEQUENTLY WITH A 14 MM BALLOON TO RELIEVE THE OBSTRUCTION. REPEAT INFERIOR VENA CAVAGRAM IMAGES REVEAL NO SIGNIFICANT RESIDUAL STENOSIS OF THE INFERIOR VENA CAVA. THERE DOES APPEAR TO BE SOME SLIGHT IRREGULARITY OF THE INFERIOR VENA CAVA AND POSSIBLY SOME SMALL FILLING DEFECTS WHICH PROBABLY REPRESENT SOME IRREGULARITY OF THE CAVAL WALL THAT OCCURRED DURING ATTEMPTED FILTER RETRIEVAL. SHORTLY AFTER DILATING THE INFERIOR VENA CAVA, THE PT'S PRESSURE RETURNED TO NORMAL. INCIDENTALLY, NOTE ALSO THAT THERE IS A QUESTIONABLE FILLING DEFECT ASSOCIATED WITH THE LEFT RENAL VEIN. INITIALLY, THIS WAS FELT TO BE A FLOW DEFECT BUT AT THIS POINT NOT CERTAIN. ATTORNEY ALLEGES THE IMPRESSION IS: ATTEMPTED REMOVAL OF THE INFERIOR VENA CAVA WHICH WAS UNSUCCESSFUL DUE TO "SCARRING" CAUSING ADHESION OF THE FILTER STRUTS INTO THE WALL OF THE INFERIOR VENA CAVA. TRANSIENT DEVELOPMENT OF OCCLUSION OF THE INFERIOR VENA CAVA FOLLOWING THE ATTEMPTED FILTER REMOVAL, AS DESCRIBED ABOVE. THIS TEMPORARY OCCLUSION WAS SUCCESSFULLY TREATED WITH BALLOON DILATATION OF THE INFERIOR VENA CAVA. QUESTIONABLE NON-OCCLUSIVE THROMBUS ASSOCIATED WITH THE LEFT RENAL VEIN VS. FLOW DEFECT, AS DESCRIBED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407588 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 2667167

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R| S