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Catalog Number UNKNOWN
Device Problem Occlusion Within Device (1423)
Patient Problem Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
Article: procedural and indwelling complications with inferior vena cava filters: frequency, etiology, and management. (b)(4). Expiration date: unknown as lot # is unknown. Catalog #: unknown but referred to as a cook günther tulip filter. Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057. Mfr date unknown as lot # is unknown. Summary of investigational findings: this complaint relates to "second case" in the above review, ie the last six images showing recurrent bilateral pe approx. 3 years after filter placement. The filter is designed to prevent pulmonary emboli from lower extremity dvt, but in this case, there was significant extension of thrombus above the level of the filter, portions of which likely had broken off and caused the patients pulmonary emboli. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. Rpn and lot # are unknown, but 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. Cook medical will continue to monitor for similar events.
Event Description
Description of event according to article: [pt] transferred to the authors¿ hospital intensive care unit with acute renal failure and recurrent bilateral pe despite an ivc filter being in place. On physical examination, the patient had extensive swelling and discoloration of the left leg with no pulses or motor or sensory function below the knee level, in keeping with dvt-induced compartment syndrome. The heart rate was 115 beats per minute, blood pressure was 118/76 mm hg, and o2 saturations on 3 liters of o2 by nasal cannula was 97%. Ultrasound of the left femoral vein revealed a deep venous thrombosis, and an outside abdominal computed tomography (ct) scan revealed an extensive left femoral, popliteal, and occlusive bilateral iliocaval thrombosis. Vascular surgery recommended endovascular treatment by interventional radiology. Under ultrasound guidance, the left popliteal vein was accessed and a 5 french vascular sheath was advanced. A limited venogram confirmed the diagnosis and extent of the disease. A cragg¿mcnamara 135/20 cm valved infusion catheter (covidien, (b)(4)) was inserted over a guidewire into the femoral vein. Thrombolysis was initiated with a bolus of 5 mg of tissue plasminogen activator (tpa) (activase; genentech, (b)(4)) followed by catheter-directed infusion of tpa at 1 mg per hour and heparin at 400 units an hour. After 8 hours, venograms of the ivc and femoral vein demonstrated persistence of the clot, venograms of the iliac, suprarenal ivc, and renal veins demonstrated patency. Thrombolysis was resumed with a bolus of 8 mg of tpa followed by an infusion of tpa at 5 mg per hour and heparin at 400 units an hour, this time parking the infusion catheter tip in the contralateral iliac vein given the extent of venous thrombosis. After 20 hours, venograms were performed once again. Improved patency was noted in the left femoral vein and ivc. Antegrade ivc flow was noted with an intraluminal central clot. Thrombolysis was continued and the catheter was advanced to the iliac vein. At 41 hours, venograms demonstrated minimal residual clot in the left femoral vein and the apex of the indwelling ivc filter. Thrombolysis was continued for another 15 hours until the clot was no longer visible on imaging. The patient¿s symptoms related to his pe and right leg dvt rapidly resolved over the next few days, and the patient was subsequently started on coumadin. He was scheduled for ivc filter repositioning but was lost to follow-up. Author's evaluation: the caudal position of the filter certainly could have contributed to caval thrombosis in addition to the patient¿s clotting factor mutation. In retrospect, consideration should have been given for repositioning the filter at the time of deployment. This patient was treated at a site where there was limited access to dedicated devices for thrombolysis and thrombectomy; therefore, the authors were able to offer stand-alone catheter-directed thrombolysis (cdt) using a relatively high dose of thrombolytic infusion. Although treatment was successful, this did expose the patient to a higher risk of bleeding and also required an extended stay in the intensive care unit. Although mechanical devices are often used in such cases, the authors determined that the use of angiojet (medrad, (b)(4)) would not have been appropriate in this case, given the history of acute renal failure. In hindsight, also given the extent of venous thrombosis and history of pe, a retrievable suprarenal filter could have been placed to protect the patient from massive pe during the procedure. Patient outcome: the patient did not experience any adverse effects due to this occurrence.
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Manufacturer (Section D)
4632 bjaeverskov
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
MDR Report Key6371123
MDR Text Key68752087
Report Number3002808486-2017-00689
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,other
Reporter Occupation
Type of Report Initial
Report Date 11/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1