MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Dyspnea (1816); Occlusion (1984); Internal Organ Perforation (1987); Thrombus (2101); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

It is alleged that the plaintiff received a gunther tulip filter implanted on (b)(6) 2007.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.

Manufacturer Narrative

Additional information: this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Pt allegedly received an implant on (b)(6) 2007 via the right common femoral vein due to prior to gastric bypass surgery.Pt is alleging occlusion, embedded and the device is unable to be retrieved.The pt further alleges blood clots, shortness of breath, post implant dvt and pain.Retrieval was attempted on (b)(6) 2007.

Event Description

This additional information received on 05/jan/2018 as follows: patient received an implant on (b)(6) 2007 via the right common femoral vein due to prior to gastric bypass surgery.Patient is alleging blood clots, shortness of breath and pain due to the device.Retrieval was attempted on (b)(6) 2007.

Manufacturer Narrative

(b)(4) corrected data based on new information received: adverse event to product problem.Serious injury to malfunction.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ/vena cava (vc) perforation, limited physical activity, worry, shortness of breath.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.Unknown if the reported limited physical activity, worry, and shortness of breath are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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 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 on (b)(6) 2007 prior to gastric bypass surgery.Patient is alleging organ and vena cava perforation, tilt, and the hook is embedded within the ivc wall.Patient further alleges "my ivc filter is still in my body and i feel like it is causing me to have blood clots.I have shortness of breath (sob).I feel like i can feel the ivc filter in the lower part of my stomach and it causes me pain." "i have shortness of breath and pain so it can be hard for me to do everyday tasks." "the filter worries me because i don't want to have it move or break and cause me permanent damage.When they tried to take it out but couldn't, they never told me about all of the risks that are associated with it.Now i just have to deal with it without knowing what could happen to me.I have not sought treatment.".

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7152003
• MDR Text Key: 95957765
• Report Number: 1820334-2017-04673
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2022
• Date Device Manufactured: 04/09/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 66 KG