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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Pain (1994); Great Vessel Perforation (2152); Bowel Perforation (2668); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# pr (b)(4).Catalog# is unknown but referred to as cook celect filter.Reporter occupation: non-healthcare professional.Summary of investigational findings: the following allegations have been investigated: ivc/duodenum perforation, tilt.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.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.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.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: it is alleged that "on an unknown date (but believed to be in (b)(6) 2008), [pt] was implanted with a cook celect ivc filter.On or about (b)(6) 2020, [pt] underwent a computerized tomography scan (¿ct scan¿) of her abdomen.On or about (b)(6) 2020, [pt] was informed that the ct scan revealed that the filter has tilted and that multiple struts are now perforating through the wall of her inferior vena cava.Additionally, one (1) strut has perforated into her duodenum and another strut contacted the vertebral body." patient outcome: it is alleged that "[pt] faces numerous health risks, including the risk of death.Because the filter likely cannot be removed as intended, [pt] will require ongoing medical care and monitoring for the rest of her life.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a2, a4, b5, b6, g2, h6.Investigation: the following allegations have been investigated: embedment, pain, mental anguish, emotional distress, physical impairment, fear.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding embedment does not change the previous investigation results for vena cava/organ perforation.Unknown if the reported pain, mental anguish, emotional distress, physical impairment, and fear are 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.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 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) 2008 via the right common femoral vein due to history of deep vein thrombosis (dvt) and inability to anticoagulate.Patient is alleging tilt, vena cava perforation, organ perforation, and embedment.The patient further alleges physical pain, mental anguish, emotional distress, physical impairment, and fear.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10710014
• MDR Text Key: 212305704
• Report Number: 3002808486-2020-00977
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 81