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 Great Vessel Perforation (2152); Anxiety (2328); Depression (2361); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Reporter occupation: non-healthcare professional.Summary of investigational findings: 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.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 or about (b)(6) 2013, [pt] was implanted with a cook celect ivc filter.[pt] has suffered serious injury as a result of the implantation of the cook celect filter.Specifically, several prongs of the cook celect filter have perforated [pt]¿s ivc with at least one of the prongs perforating [pt]¿s duodenum." patient outcome: it is alleged that "the [pt] faced numerous health risks, including the risk of death.The full impact of [pt]¿s cook celect filter on her health is unknown.".

Event Description

Patient allegedly received an implant on (b)(6) 2013 via the right internal jugular vein due to deep vein thrombosis (dvt), followed by a successful retrieval on (b)(6) 2019.Patient is alleging vena cava and organ perforation.The patient further alleges "the filter perforated my vena cava and my duodenum; this caused me to live with fear and anxiety.Due to the filter¿s failure i underwent a surgical procedure to have it removed," as well as depression.Report from ct (computed tomography): "positive for caval perforation.Superior extent of ivc filter superior l3 vertebral body.Inferior extent inferior l4 vertebral body.A total of 7 prongs have perforated ivc series 2 image 38.Maximum distance prongs perforated 13.05 mm series 2 image 38.Coronal images 7.18 degree tilt left to right series 601 image 62.Sagittal images 3.40 degree tilt anterior posterior series 602 image 81.Diameter of ivc directly above filter 21.54 mm x 13.55 mm series 2 image 29.Attention: a prong has perforated the duodenum best appreciated on series 2 image 38." retrieval report (successful): "filter was removed without difficulty.The filter was intact with all the legs intact there were no remnants remaining after filter removal.2.No evidence of ivc perforation was seen.".

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, b2, b5, b6, b7, d7, h6.Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: tilt, fear, anxiety, depression.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.Unknown if the reported fear, anxiety, and depression 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.

• 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: 10815321
• MDR Text Key: 215484360
• Report Number: 3002808486-2020-01027
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 50