MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Collapse (1099); Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombus (2101); Stenosis (2263)

Event Date 01/08/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook ivc filter initial reporter occupation: non-healthcare professional.(b)(4).Summary of investigational findings: the reported allegations have been investigated based on the information provided to date.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.No evidence to suggest product was not manufactured according to specification.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to categorization form: [pt] alleges: "ivc thrombotic occlusion - consisting of an occluding thrombus in the ivc after filter insertion"."ivc filter has caused ivc stenosis and total occlusion of the inferior ivc".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

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: embedded, stenosis, filter collapse, ivc fibrosis, venous stasis/antibiotics, bilateral leg ulcers, depression, limited physical activity.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 filter collapse, ivc fibrosis, venous stasis/antibiotics, bilateral leg ulcers, depression, limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in 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.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 relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received an implant on (b)(6) 2008 via the right groin due to pulmonary embolism prophylaxis; undergoing total knee replacement.It has been reported the filter was successfully removed on (b)(6) 2018 due to venous insufficiency, lower extremities.Patient is alleging collapse and fibrosis of ivc (inferior vena cava) from junction of the iliac veins to the ivc filter and ivc thrombotic occlusion-consisting of an occluding thrombus in the ivc after filter insertion-ivc filter has caused ivc stenosis and total occlusion of the inferior ivc.Patient notes and further alleges experiencing "five (5) years of venous status [sic] treatments, continuing today.Ulcers on both legs.Ivc filter was embedded and needed to be surgically removed.Filter caused a condition of venous stasis, which i have and am being treated for".Further, patient notes the need for antibiotic treatment, limited physical activity and depression.Per the (b)(6) 2008 ivc filter placement: "a cook select filter is in the proper position, co-axial, just inferior to the renal veins.Conclusion: 1.Normal inferior vena cava.2.Successful deployment of a cook-select ivc filter".Per the (b)(6) 2017 bilateral lower extremity venogram: "impression: 1.Bilateral lower extremity venograms were performed which demonstrates no dvt.No svt identified.2.Total occlusion of the inferior ivc.There is an ivc filter in place this appears to be a retrievable tulip filter.I suspect this is totally occluded.3.Large collateral bypassing veins are identified bilaterally in the pelvic region.4.Despite multiple attempts was unable to gap through the occlusion and into the ivc.This appears chronic i do not believe we would be able to get through this occlusion and be able to open up the ivc.This appears to be a chronic occlusion of many years".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9436739
• MDR Text Key: 185002390
• Report Number: 3002808486-2019-01946
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR
• Patient Weight: 113