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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Pain (1994); Perforation of Vessels (2135); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.(b)(4).Summary of investigational findings: it has not been possible to investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿celect filter - ivc filter migration, pain." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Unknown if the reported pain is directly related to the filter.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 of event according to categorization form: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014".[pt] alleges: "migration of sheath diagnosed in 2018".Physician has not recommended removal, and removal has not been attempted.Patient outcome: [pt] alleges "post-implant pain from filter migration; pain starting 2017 - current".Location of pain: chest, frequency: chronic.

Event Description

Patient received implant on 06jul2014 via the right common femoral vein.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# pr254059.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Investigation is still in progress.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.

Manufacturer Narrative

Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

Manufacturer Narrative

Investigation: the following allegations have been investigated: vena cava (vc) perforation.Investigation is reopened 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.Catalog number and lot number are unknown, but the filter celect is manufactured and inspected according to controls.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 following information is alleged: the patient received a cook celect filter on (b)(6) 2014.The patient was informed that multiple struts perforated through the ivc.

Event Description

Patient allegedly received an implant in (b)(6) 2014 due to pulmonary embolism (pe).The patient alleges anxiety, worry, fear, and limited mobility.

Manufacturer Narrative

Investigation the following allegations have been investigated: anxiety, worry, fear, and limited mobility.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported anxiety, worry , fear, and limited mobility is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown, but the filter celect 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.

• Brand Name: UNKNOWN
• 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: 8369127
• MDR Text Key: 137113196
• Report Number: 3002808486-2019-00240
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• 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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/31/2019
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 191 KG