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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Device Tipped Over (2589); Insufficient Information (3190)

Patient Problems 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 gunther tulip filter.Occupation: non-healthcare professional.Pma/510(k): k172557.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 günther tulip filter on (b)(6) 2016.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Event Description

Per a (b)(6) 2018 independent review of a computed tomography (abdomen and pelvis) performed (b)(6) 2018: "positive for caval perforation.Superior extent of ivc filter mid l2 vertebral body.Inferior extent mid l3 vertebral body.A total of 4 prongs have perforated the ivc series 9 image 65.Maximum distance prongs perforated 8 mm series 9 image 65.Coronal images 7 degree tilt right to left series 601 image 60.Sagittal images 5 degree tilt anterior to posterior series 602 image 47.Diameter of ivc directly above filter 21 mm x 19 mm series 9 image 44.Attention: a metallic fragment is seen anterior to ivc filter.This is of unknown origin.This does not appear to be a broken portion of ivc filter and is best appreciated on images 9/48 and 602/49".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b1, b5, b6, h6 (patient and device codes).Investigation: 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 and lot numbers are unknown.The alleged tulip 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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 via the right common femoral vein due to deep vein thrombosis (dvt) and contraindication to anti-coagulation.Patient is alleging vena cava perforation.Patient notes and further alleges experiencing "anxiety of having a filter that could fail further at any time, but that cannot be retrieved without a serious surgery.I am worried because my ivc filter struts have perforated my vena cava".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: anxiety, worry.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 and worry are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 10134579
• MDR Text Key: 194532997
• Report Number: 3002808486-2020-00598
• 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: 09/18/2020

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: 05/20/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 07/14/2020; 08/31/2020
• Supplement Dates FDA Received: 07/27/2020; 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 77