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 Problems Material Twisted/Bent (2981); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.(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 celect filter on (b)(6) 2010".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

Exemption number e2016032.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.G1) (wce only).Name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.H6: patient code:  vessels, perforation of (2135) - not listed in ifu, vessel or plaque, device embedded in (1204) - not listed in ifu.H6: device code:  unintended movement (3026) not listed in ifu, material twisted / bent (2981) - not listed in ifu.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) 2010 via the right common femoral vein due to pulmonary embolism, ivc required prior to total knee replacement and knee surgery.Patient is alleging "tilt, vena cava perforation, legs bent and embedded.Patient further alleges "pain and suffering, and unnecessary surgery" without further details.Successful retrieval of filter took place on (b)(6) 2017 and "surgery was through the jugular and also through groin".

Event Description

No additional information provided at this time.

Manufacturer Narrative

Exemption number e2016032.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.G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Additional information- investigation- 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 'tilt, vena cava perforation, legs bent, embedded'.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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Unknown if the reported pain/discomfort is directly related to the filter.Unknown if the reported bent filter legs, suffering, unnecessary surgery is directly related to the filter and unable to identify corresponding failure mode(s) at this time.No relevant notes found on work order or device lot.No other complaints on lot.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.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 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: 7901016
• MDR Text Key: 121438358
• Report Number: 3002808486-2018-01115
• 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
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2012
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2603643
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/11/2018
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 84