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 Abdominal Pain (1685); Perforation of Vessels (2135); No Information (3190)

Event Date 03/12/2018

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

Additional information received from short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation and tilt.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: vena cava (vc) 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.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 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

Report from ct (computed tomography): "there is appears to be a celect inferior vena cava filter in place.The apex of the filter is located at the inferior aspect of the origin of the right renal vein (most caudal renal vein).There is minimal horizontal tilt by approximately 4 degrees to left.The filter is also tilted 6 degrees posteriorly.The apex of filter is closely associated with the posteromedial wall of the inferior vena cava.All the filter struts are intact however, all the struts have essentially perforated the caval walls.The largest distance of perforation is by an anterior strut which is perforating the wall by approximately 6 mm.There is a lateral strut which is closely associated with the anterior wall of the aorta there is an additional anteromedial strut which is transgressing the wall by approximately 4 mm and is in close proximity to the duodenum however, there is a clear fat plane between the strut and the duodenal wall.There is standard configuration of the visualized inferior vena cava.There is no evidence of caval stenosis on this noncontrast exam.".

Event Description

Patient allegedly received an implant on (b)(6)2014 via the right internal jugular vein due to spinal surgery with bilateral pulmonary emboli (pe) and inability to anticoagulate.Patient is alleging "abdominal pain and blood in stool.My filter has tilted and the legs of the filter have punctured through the wall of the ivc into my aorta and close to my small bowel (duodenum).".

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, b3, b5, b6, b7, 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: aorta perforation, abdominal pain, blood in stool.Unknown if the reported abdominal pain, blood in stool are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The additional information regarding aorta perforation does not change the previous investigation results for vena cava perforation.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 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: 9796610
• MDR Text Key: 182292764
• Report Number: 3002808486-2020-00270
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• 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: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 37 YR
• Patient Weight: 195