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Catalog Number UNKNOWN
Device Problem Occlusion Within Device (1423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: investigation is based on article and image review. Patient suffered a complex pelvic fracture, while abroad, resulting in a 14 day delay in surgical intervention. In the preoperative period, patient developed pulmonary emboli and was started on heparin as well as treated with an ivc filter inserted prior to surgery. On the day of surgery, one day following insertion of the ivc filter, the heparin was stopped. During the surgical exposure, the operating physicians encountered ¿torrential bleeding¿ and the surgery was abandoned with the wound packed for hemorrhage control. Ct angiogram was performed immediately following the surgery did not demonstrate any large vascular injury, but did demonstrate an expansile appearance to the ivc and iliac veins, as well as retroperitoneal edema, findings which suggest acute thrombosis of the ivc and iliac veins. The celect filter demonstrated no significant tilt and no penetration. Unfortunately, the phase of contrast enhancement was not ideal for evaluation of the inferior vena cava and pelvic deep venous thrombosis, however, given the expansile appearance, this is highly suspicious for complete thrombosis. There was no preoperative ultrasound performed of the lower extremities to evaluate current dvt. It is hypothesized by the author that the manipulation of the femoral vessels may have dislodged a dvt resulting in acute occlusion of the ivc at the level of the filter. Given that the patient was anticoagulated up until the time of surgery and the surgery was performed one day after placement of the ivc filter, it is very unlikely that the filter acted as a nidus for ivc thrombosis, but rather performed the intended function by preventing migration of dvt to the pulmonary arteries. The consequence of this function resulted in the acute occlusion of the ivc, and therefore contributed to the elevated venous pressures and extensive bleeding encountered during surgery. It is well-established that ivc filters decrease the risk of symptomatic pulmonary emboli, at the cost of increasing the risk of lower extremity in caval thrombosis over time. However, given the sequence of events and timeframe discussed in this case report, the more likely explanation is the filter performed its intended function. 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. 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.
Manufacturer Narrative
(b)(4). Article: excessive venous bleeding in a patient with acetabular pelvic fracture secondary to inferior vena cava filter occlusion. Nahas et al, 2012. Bmj case rep. 2012 nov 30;2012. Pii: bcr2012006712. Doi: 10. 1136/bcr-2012-006712. Catalog# is unknown but referred to as cook celect filter. Since catalog# is unknown 510(k) could be similar to either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Investigation is still in progress.
Event Description
Description of event according to article: filter occlusion due to fixation procedure: on holiday in (b)(6), the patient sustained left acetabulum fracture because of a quad bike injury. As he was abroad the fracture was not fixed within the ideal 10 days. Preoperative ct scan confirmed the development of pe thus a ivcf was inserted. The attempts to fix the pelvis was extensive and required among other 12 units of blood. Postoperative ct revealed a heterogeneous appearance of distended iliac vein and ivc suggesting venous hypertension. This indicated that the ivc filter was blocked as a result of the attempted fixation procedure. Removing the filter was not an option as it was stopping caudal seeding of thrombi. Patient outcome: the ivc filter was left in situ with the reasoning that he should be given time to establish venous collateral circulation. The patient did not require any additional procedures due to this occurrence. The patient did not experience any adverse effects due to this occurrence.
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Manufacturer (Section D)
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
MDR Report Key6662685
MDR Text Key250948039
Report Number3002808486-2017-01344
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2017
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?
Distributor Facility Aware Date06/02/2017
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial