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

Catalog Number IGTCFS-65-UNI-CELECT-PERM

Device Problems Structural Problem (2506); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Injury (2348); Disability (2371); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog # is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.(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 cook 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.

Event Description

No additional information provided at this time.

Manufacturer Narrative

Exemption number e2016032.(b)(4).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 'vc perf, tilt, mental/physical pain, permanent injuries, diability'.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 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 mental pain and suffering, severe and permanent injuries requiring past and future medical treatment, disability, impairment, loss of enjoyment of life, loss of care, comfort 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.

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.Patient code: vessels, perforation of (2135), listed in ifu.Device code: unintended movement (3026) [device tilt], not listed in ifu.Appropriate term/code not available (3191) [device perforation], not listed in ifu.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.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) 2010 via right common femoral vein due to deep vein thrombosis (dvt) with pulmonary embolism (pe).Patient alleges tilt, vena cava perforation.Patient further alleges to have experienced mental and physical pain and suffering, severe and permanent injuries requiring past and future medical treatment, and resulting in disability, impairment, loss of enjoyment of life, loss of care, comfort.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ perforation.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.20 devices in lot.No other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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 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

Per computed tomography report, "5 mm small bowel, and 4 mm mesenteric perforation" "tilting with the apex against the ivc wall".

• Brand Name: COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
• 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 DK-46 32; DA DK-4632
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7994400
• MDR Text Key: 124659698
• Report Number: 3002808486-2018-01223
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2011
• Device Catalogue Number: IGTCFS-65-UNI-CELECT-PERM
• Device Lot Number: E2451533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/04/2018
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2009
• 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
• Patient Weight: 136 KG