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

Catalog Number IGTCFS-65-FEM-CELECT-PERM

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] on (b)(6) 2007, was implanted with a cook celect@vena cava filter.Shortly after the implant on or around (b)(6) 2007, [pt] experienced chest pain and coughing up blood".Patient outcome: it is alleged that "[pt] continued to suffer symptoms and physical limitations, and she requires ongoing medical care, as a result of the multiple surgeries needed to remove the cook filter".

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.(b)(4) summary of investigational findings: no conclusion can be drawn based on the limited information provided that "[pt] on or about (b)(6) 2007, [pt] was implanted with a cook celect@vena cava filter at (b)(6) in (b)(6).Shortly after the implant on or around (b)(6) 2007, [pt] experienced chest pain and coughing up blood" and "[pt] continued to suffer symptoms and physical limitations, and she requires ongoing medical care, as a result of the multiple surgeries needed to remove the cook filter" - nor is it possible to confirm any relation to the filter.Medical records are unknown.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk.Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques.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 medical will continue to monitor for similar events.

Event Description

Description according to initial reporter: it is alleged that "[pt] on (b)(6) 2007, was implanted with a cook celect@vena cava filter.Shortly after the implant on or around (b)(6) 2007, [pt] experienced chest pain and coughing up blood".Patient outcome: it is alleged that "[pt] continued to suffer symptoms and physical limitations, and she requires ongoing medical care, as a result of the multiple surgeries needed to remove the cook filter".

Manufacturer Narrative

Exemption number e2016032.(b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction, corrected to (b)(6), 510(k) updated to k073374.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 09/01/2017 as follows: patient received an implant on (b)(6) 2007 via the common femoral vein due to pulmonary embolus, pulmonary hypertension.Patient is alleging bleeding, pain in right side, felt filter shift inside body, hemoptysis.

Manufacturer Narrative

Exemption number e2016032.(b)(4).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 'celect, bleeding, pain in right side, chest pain, coughing up blood, difficult to remove'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported bleeding, pain in right side, chest pain, coughing up blood 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

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Exemption number e2016032.(b)(4).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 'celect, vc perforation, bleeding, pain in right side, chest pain, coughing up blood, difficult to remove'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported bleeding, coughing up blood 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

Exemption number e2016032.(b)(4).Investigation: investigation is reopened due to additional information provided.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 'celect, chronic pe, bleeding, pain, hemoptysis, difficult to remove, filter shift in body, pulmonary edema'.Cook will reopen its investigation after further information concerning alleged patient sufferings is received and will supplement in accordance with 21 c.F.R.803.56 when appropriate.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.Unknown if the reported pain or bleeding is directly related to the filter.Unknown if the reported hemoptysis or pulmonary edema 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.

Event Description

No additional information provided at this time.

Manufacturer Narrative

(b)(6).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

Per ct report: "chronic pulmonary emboli in the right middle and bilateral lower lobes.These are seen on prior exam in 2008.No acute pulmonary embolus.".

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Name and address for importer site: (b)(4).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

No additional information provided at this time.

• Brand Name: COOK CELECT 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: 5839362
• MDR Text Key: 50904548
• Report Number: 3002808486-2016-00814
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2009
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2065789
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/01/2016
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 59