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

Catalog Number UNKNOWN

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Patient allegedly received an implant on (b)(6) 2010 via the right internal jugular vein.(b)(6) 2017, per a report from computed tomography (ct); ¿addendum is being made for further description of the ivc filter.The tip of the ivc filter is located at the level of the right renal vein and approximately 0.3 cm inferior to the left renal vein.The prongs of the ivc filter extend outside of the ivc.One prong extends medially and touches the wall of the abdominal aorta, best appreciated on axial series 2 images 36-38.Another prong extends posteriorly and contacts/extends into the l3-l4 intervertebral disc.There is mild to moderate anterior apex angulation/tilt of the filter.¿.

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Appropriate term/code not available (3191) was selected for the alleged device tilt.The following allegations have been investigated: vena cava perforation, tilt.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.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.Catalog number and lot number are unknown; however, there is 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.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.

Manufacturer Narrative

The following fields were updated per additional information received: a4, b2, b5, b6, b7, and h6.Investigation: the following allegations have been investigated: organ-aortic/vertebral body perforation, headache/migraine, stomach issues, anxiety, mental anguish, stress, worry.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 organ-aortic/vertebral body perforation does not change the previous investigation results for vena cava perforation.Unknown if the reported headache/migraine, stomach issues, anxiety, mental anguish, stress, worry 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.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

Patient allegedly received an implant on (b)(6) 2010 due to pulmonary embolism.The patient alleges vena cava perforation and organ-aortic/vertebral body perforation.The patient further alleges headaches, migraines, stomach problems, anxiety, mental anguish, stress, and worry.

• 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: 8958920
• MDR Text Key: 156409976
• Report Number: 3002808486-2019-01380
• 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,Followup
• Report Date: 10/06/2020

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: 08/14/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 03/03/2020; 09/17/2020
• Supplement Dates FDA Received: 03/11/2020; 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 113