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

Catalog Number IGTCFS-65-FEM

Device Problems Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Information provided by (b)(6).Occupation: non-healthcare professional.Investigation: filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.This report includes information known at this time.A follow up report will be submitted should additional information become available.Udi: (b)(4).

Event Description

It is alleged that the patient received a cook gunther tulip filter and is alleging fracture.Hospital and medical records have not been provided.

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.The following allegations have been investigated: pulmonary embolism, fracture, vena cava perforation, and thrombosis.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.A total of (b)(4) devices were manufactured in the reported lot.To date, one additional complaint has been reported against this lot (5508927).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 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

The following additional information is alleged: the patient experienced an acute embolism and thrombosis, despite having the filter implanted approximately a year and 10 months prior.The patient ultimately had to undergo a recanalization utilizing thrombolytic therapy and balloon angioplasty 8 days later.During this procedure, it was noted that the patient's filter had fractured with one of the struts having separated inferiorly from the filter body.Approximately 3 years and 2 months after this procedure, it was noted that one of the filter leg struts had extended beyond the wall of the vena cava and was touching the aorta.

Event Description

Patient allegedly received a gunter tulip ivc filter implant on (b)(6) 2015 via right femoral vein due to deep vein thrombosis (dvt)/ pulmonary embolism (pe).Per report from thrombolysis: "impression: extensive ileal caval venous thrombosis as outlined above.Please note that the patient's ivc filter has a fractured leg which is separated inferiorly from the filter body.Successful recanalization utilizing thrombolytic therapy as well as balloon angioplasty." per report from computed tomography 1: "ivc filter: the ivc filter tip is just below the level of the renal vessels, the tip is touching the posterior wall of the ivc.One of the leg struts extends beyond the wall of the cava and touches the aorta two other struts appear to extend just beyond the wall of the ivc coronally the tip of the filter is parallel to the ivc." per report from computed tomography 2: "findings: filter type: cook.Ivc stenosis: no.Filter cone position: below the renal veins.Filter migration: no.Filter fracture/bending: no.Filter tilt: yes.Filter penetration: yes.Other findings: yes.Impressions: the filter is tilted to the left with its proximal cone on the ivc wall.Axial image 31.The anterior right strut penetrates 5 mm through the ivc wall.Sagittal image 42.The anterior left strut penetrates 13 mm through the ivc wall.Coronal image 42.The posterior right strut penetrates 0 mm through the ivc wall.The posterior left strut penetrates 26 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes.Coronal image 45 and sagittal image 46.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ perforation, tilt.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.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.A total of (b)(4) devices were manufactured in the reported lot.To date, one additional complaint has been reported against this lot number.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.

Manufacturer Narrative

Cook inc.Has been unable to submit reports due to issues with receiving new ssl certificates for esg as2 trading partners from the esg help desk.This issue was discovered over the weekend of (b)(6) 2023.Cook has been in communication with the fda regarding this issue and was provided the needed security certificate on (b)(6) 2023.Questions and answers about emdr - electronic medical device reporting - guidance for industry, user facilities and fda staff, section d: ¿¿ if a manufacturer or importer is unable to submit a report on time due to an outage affecting the esg or the cdrh emdr processing system, it may document its attempts at timely filing in block h10 for the affected reports and submit reports electronically as soon as the esg or cdrh emdr processing system is operational.¿ an email has been sent to fda as the guidance instructs informing fda of the information set forth in the guidance regarding these delayed submissions.The report was sent 04dec2023.

• 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 ; 8123392235
• MDR Report Key: 11390018
• MDR Text Key: 234345374
• Report Number: 1820334-2021-00489
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2023

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: 11/01/2017
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 5508927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/27/2021
• Supplement Dates Manufacturer Received: 11/24/2021; 10/31/2023; 11/30/2023
• Supplement Dates FDA Received: 12/14/2021; 12/04/2023; 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female