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

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problems Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165); No Information (3190); Suicidal Ideation (4429); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Reporter occupation: non-healthcare professional.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) 2014.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Manufacturer Narrative

Investigation: the following allegations have been investigated: pulmonary embolism (pe), chronic embolism, vena cava (vc) perforation, embedment, deep vein thrombosis (dvt)/stenosis/occlusion, swelling, water retention, limited mobility, arthritis, suicidal, pain.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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, vena cava perforation, vena cava penetration.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.Unknown if the reported swelling, water retention, limited mobility, arthritis, suicidal, and pain 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 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.

Event Description

The patient received an implant due to pulmonary embolism (pe).The patient alleges vena cava perforation, chronic embolism and thrombosis, and embedded.The patient further alleges walking pain, inability to walk, legs bound because of swelling, water retention, arthritis, suicidal, and stenotic/occlusion/caval narrowing.Successful ultra sound guided right common femoral vein filter removal (b)(6) 2018 due to inability to walk and blood clots.On (b)(6) 2017, per a report from venogram; ¿findings: the left femoral popliteal vein, common femoral vein, external iliac vein, common iliac and the inferior vena cava thrombosed.The clot extends through the filter and just above the filter.Using a kumpe catheter and a stiff glidewire, the occlusion throughout the leg was crossed all the way into the ivc.The catheter was advanced above the filter and a contrast injection performed, which showed that the ivc above the filter was patent.A rosen wire was then advanced through the kumpe catheter into the ivc and the catheter was then removed.¿ "the patient would be started at tpa at 0.75 mg an hour through the side port of the sheath".On (b)(6) 2017, per a report from angiogram; ¿findings: the femoropopliteal venous segment is now free of clot and was successfully lysed; however, the iliac vein and particularly the inferior vena cava thrombosis is completely unaltered despite the extended tpa dosing with the ekos catheter.The ivc filter remains thrombosed.The suprarenal ivc is widely patent.The sheath was removed with manual pressure being held over the access site.¿ on (b)(6) 2018, per a report from computed tomography; ¿impression: 1.Chronic appearing iliocaval thrombosis with stenotic and/or occluded distal inferior vena cava and common iliac vessels.Infrarenal ivc filter remains in place, with legs extending beyond the lumen of the ivc, possibly embedded.¿ on (b)(6) 2018, per a report from retrieval report (successful); ¿impression: 1.Inferior vena cava filter with severe caval narrowing.2.Narrowing and thrombosis of the right external and common iliac vessels.3.Severe narrowing/occlusion of the left common iliac vein.4.Successful removal of infrarenal inferior vena cava filter.5.Balloon venoplasty of the distal cava, left and right iliac system with recannulization and central flow.6.Persistent chronic appearing thrombus in the right common femoral and external iliac vein with aspiration thrombectomy with post thrombectomy improved appearance.¿.

• Brand Name: COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11130236
• MDR Text Key: 225502328
• Report Number: 3002808486-2021-00017
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2017
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3196105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 104