MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JUG-CELECT-PERM

Device Problems Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506)

Patient Problems Pulmonary Embolism (1498); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3 ¿ occupation: non-healthcare professional investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: pulmonary embolism (pe), inferior vena cava (ivc)/aorta/renal vein perf, deep vein thrombosis (dvt), unable to retrieve, meds required, limited physical activity.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications the filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Unknown if the reported meds required, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.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 will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow up report will be submitted should additional information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received a cook celect filter on (b)(6) 2010 via the right internal jugular vein due to bilateral ankle fractures.Patient is alleging the device is unable to be retrieved, struts of ivc filter extend beyond wall of ivc, and, strut passes through anterior wall of distal aorta above the level of the bifurcation.Patient notes and further alleges "i continue to take eliquis for blood clots", "i no longer engage in strenuous physical activity or heavy lifting", "i don't have a history of blood clots prior to placement of the ivc filter.I have been treated for blood clots in my legs and lung", per a computed tomography (ct) report: "ivc filter with multiple legs extending through the wall of the ivc, of uncertain clinical significance.No prior studies available for comparison".Per a ct report: "impression 1.Evaluation of smaller pulmonary arteries is limited by motion, however there is a area of hypoattenuation in the left lower lobe artery which likely represents pulmonary embolus.There are additional filling defects which are favored to be artifactual.No evidence of right heart strain.2.Lnfrarenal ivc with extensive thrombus extending from the bilateral femoral veins to above the ivc filter.One of the ivc filter prongs penetrates into the right common iliac artery.There are multiple thrombosed pelvic veins".Per a ct report: "ivc filter in place.The struts of the ivc filter extended beyond the wall of the ivc.One strut appears to pass through the anterior wall of the distal aorta just above the level of the bifurcation".

• Brand Name: COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 18899907
• MDR Text Key: 337619227
• Report Number: 3002808486-2024-00047
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002483729
• UDI-Public: (01)00827002483729(17)120721(10)E2623091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2012
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2623091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male
• Patient Weight: 79 KG