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

Catalog Number IGTCFS-65-1-FEM-CELECT

Device Problems Failure to Capture (1081); Device Issue (2379); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Occlusion (1984); Internal Organ Perforation (1987); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of (b)(4).Catalog# is unknown but referred to as cook celect filter (b)(4).Since catalog# is unknown 510(k) could be either k061815, k073374 or k090140.(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2011".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: product problem to adverse event and product problem.Malfunction to serious injury.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'ivc occlusion, chronic bilateral iliofemoral thrombosis, swelling, bruising, circulation probs'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Unknown if the reported bruising, circulation problems is directly related to the filter and unable to identify corresponding failure mode(s) at this time.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.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 11/01/2017 as follows: patient received an implant on (b)(6) 2011 via the right common femoral vein due to closed head injury with subdural hematoma and deep vein thrombosis.Patient experiences ivc occlusion with presumed chronic thrombus extending from the bifurcation to the level of the filter and bilateral iliofemoral thrombosis.Patient is alleging swelling, bruising and loss of circulation in legs due to the filter.Patient alleges that the device is ineffective.

Event Description

Patient allegedly received an implant on (b)(6) 2011 due to closed head injury with hematoma and dvt.Patient is alleging vena cava perforation, [ineffective, blood clots repeatedly traveled past filter], [bilateral iliofemoral thrombosis with associated ivc thrombosis extending to level of ivc filter].Patient suffers from ongoing swelling and bruising in legs, as well as continued problems with blood flow.¿.

Manufacturer Narrative

H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Corrected data: b5: [ineffective, blood clots repeatedly traveled past filter] and h6 device code (failure to capture (1081).Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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, vena cava perforation, vena cava penetration.Unknown if the reported "blood clots repeatedly traveled past filter" is directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.The following allegations have been investigated: vena cava perforation, "blood clots repeatedly traveled past filter".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 medwatch report will be submitted if additional relevant information becomes 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

11feb2022, per a report from computed tomography; ¿there does appear to be narrowing caliber at the superiormost aspect of both stents just below the renal vein similar to the reference exam, of uncertain functional significance.There is also an ivc filter in the infrarenal ivc which is distorted/displaced by the traversing stents.Metal struts from the filter appear to extend external to the ivc into the retroperitoneum with one extending into the anterior aspect of the l3/l4 disc space series 602 image 98 and another extending into the right lateral aspect of the abdominal aorta at the uppermost l4 level series 3 image 154 which is also stable.¿ 11feb2022, per a report from medical opinion (ct report dated 11feb2022); ¿findings: review of the ct scan provided demonstrates bilateral iliac vein stents terminating inferior to an ivc filter located at approximately the l2-3 level.There are prominent subcutaneous anterior abdominal wall collateral vessels/varices present.In addition, there are five (5) pathologic ivc filter component penetrations, extending greater than 3 mm beyond the perceptible exterior wall of the inferior vena cava, at the 12, 3, 5 and 9 o¿clock positions.No organ penetration.Penetrates right medial aortic wall.Penetrates l3-4 intervertebral disc space and is in contact with superior end-plate of l4.¿ various dates, medical opinion; ¿positive for perforation (grade 3) and migration, negative for tilt.Cavagram/placement of cook celect ivc filter (b)(6) 2011 - cook celect ivc filter sup l2 to inf l3.Tilted to left 13 degrees.Ct cap with contrast (b)(6) 2011.Ivc filter sup l2 to mid l3.No migration.No significant tilt.Coronal 12 degrees to left.Grade 1 perforation.Ct abd/pelvis without contrast (b)(6) 2012.Ivc filter sup l2 to mid l3.No migration.No significant tilt.Coronal 11 degrees to left.Grade 1 perforation.Ct cap with contrast (b)(6) 2018.Stents x2 extending from ivc to bilateral renal veins.Ivc filter sandwiched between stents l2-3 to sup l4.Caudal migration (2cm).No significant tilt.Coronal 10 degrees to left.Grade 3 perforation.Left lateral strut abuts aorta (5mm).Posterior strut (20mm)3.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b5, b6, h6.Investigation the following allegations have been investigated: organ/aorta perforation, migration, tilt.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.20 devices in lot.No relevant notes on work order.The product 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 medwatch report will be submitted if additional relevant information becomes 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.

• Brand Name: COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov, IN 47404 ; 8004574500
• MDR Report Key: 6943380
• MDR Text Key: 89286075
• Report Number: 3002808486-2017-01958
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/21/2017
• Date Manufacturer Received: 11/15/2022
• Date Device Manufactured: 09/01/2011
• 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; Other
• Patient Sex: Male
• Patient Weight: 127 KG