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 Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.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

It is alleged that "[pt] received a cook celect filter on (b)(6) 2011.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: organ/vena cava (vc) perforation, shortness of breath (sob), lower limb pain/swelling, limited mobility, fear/anxiety.Investigation is re-opened 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 shortness of breath (sob), lower limb pain/swelling, limited mobility, fear and anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right internal jugular vein due to a saddle pulmonary embolism.The patient alleges vena cava and organ perforation.The patient further alleges shortness of breath, chronic lower limb pain and swelling, limited mobility, fear, and anxiety.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: acute deep vein thrombosis (dvt).Investigation is reopened due to additional information provided.The reported allegations have been further 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 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 alleges acute deep vein thrombosis.(b)(6) 2019, per a report from computed tomography; ¿there is an ivc filter below the level of the renal veins.There are kissing stents in the ivc below the level of the ivc filter which extend into both common and external iliac veins.There is acute thrombus distending the distal left external iliac vein and extending into the left common femoral and proximal femoral and profunda femoris veins.¿ (b)(6) 2019, per a report from computed tomography 2; ¿ivc filter is infrarenal in position.The posterior filter struts is seen piercing the posterior wall and is seen impinging the prevertebral structures.The anterior filter struts is seen piercing the ivc wall, left strut is seen piercing the aorta (32.58mm), central strut is seen piercing the ivc (26.92mm) the right anterior filter strut is piercing the ivc (22.81mm).No ivc filter fracture noted.¿.

Manufacturer Narrative

Investigation: the following allegations have been investigated: fracture, chronic deep vein thrombosis (dvt).Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.The additional information regarding chronic deep vein thrombosis (dvt) does not change the previous investigation results for acute dvt.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.

Event Description

(b)(6) 2021, per a report from computed tomography; ¿there are venous stents extending from the bilateral external iliac arteries through the common iliac arteries and into the infrarenal ivc, stents project through a retained ivc filer.Fractured ivc filter fragments with extension of ivc struts into the retroperitoneum are again noted stable from prior examination.The venous stents appear grossly patent.¿ (b)(6) 2021 ultrasound bilateral legs: "positive occlusive dvt right common femoral, proximal greater saphenous, femoral and popliteal veins.Small amount of nonocclusive thrombus in the right popliteal vein has linear echogenic appearance and is favored chronic".

• 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: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 10249418
• MDR Text Key: 198129962
• Report Number: 3002808486-2020-00695
• Device Sequence Number: 1
• Product Code: DTK
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2013
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2738320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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
• Patient Sex: Male