MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-JUG-TULIP

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

Patient Problems Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); 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

It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2018.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Event Description

Patient allegedly received an implant via the right internal jugular vein was accessed due to bariatric surgery.Patient is alleging tilt and vena cava perforation.Patient further alleges anxiety, fear, pain, physical limitations, depression, and bipolar disorder.

Manufacturer Narrative

Additional information: investigation.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 bipolar, depression, anxiety, fear, pain, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on wo for device no other complaints on lots.The following allegations have been investigated: bipolar,depression,anxiety, fear, pain, physical limitations.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

Implant report: ".The right internal jugular vein was accessed." "infrarenal deployment of ivc filter." "we then deployed the retrievable ivc filter per ifu with <15 degrees tilt." report from computerized tomography (ct): "ivc filter assessment." "ivc shows anterior tilt touching the ivc wall.Its tip located about 2.4 cm below the right renal vein.The filter prongs are expanding beyond the wall of the ivc raising concern for perforation.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: investigation 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# are unknown.The following allegations have been investigated: vena cava perforation, 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.The following fields were updated per additional information received: a2, a4, b1, b5, b6, b7, h6.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: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10269665
• MDR Text Key: 198694509
• Report Number: 3002808486-2020-00712
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

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 Expiration Date: 03/26/2021
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/14/2020; 08/31/2020
• Supplement Dates FDA Received: 07/29/2020; 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 100