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

Catalog Number IGTCFS-65-FEM

Device Problems Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Chest Pain (1776); Dyspnea (1816); Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Non-healthcare professional investigation the reported allegations have been further investigated based on the information provided to date.The following allegation has been investigated: vena cava perforation.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.Catalog and lot # are unknown, however, the alleged tulip 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.

Event Description

The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2007 and underwent a computed tomography (ct) scan, approximately 10 years and 9 months later, which revealed that the patient's ivc filter had moved since its implantation as several struts were now perforating through the patient's ivc wall.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received an implant via the right common femoral vein post trauma.Patient is alleging device tilt and vena cava perforation.Patient notes and further alleges experiencing "chest pain and shortness of breath", physical limitation per a computed tomography (ct) abdomen without contrast: "there is an inferior vena caval filter.The superior margin of the filter is located approximately 2.3 cm inferior to the level the renal veins.The filter is tilted anterior medially at its superior aspect and is close to but not definitely abutting the adjacent wall of the inferior vena cava.There is no fracture of the struts of the filter.The strut extending laterally to the right extends 5.3 mm beyond on the wall of the inferior vena cava, the anterior strut extends approximately 4 mm beyond the wall the inferior vena cava".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b5, b6, b7, d1, d4, g4, h4, h6 (patient and device codes) 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: vena cava perforation, tilt, chest pain, dyspnea, physical limitations.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.Unknown if the reported chest pain, dyspnea, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 10 devices were manufactured in the reported 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 current 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

Additional information has been provided which alleges organ perforation.Patient also notes and alleges a physician commented the removal of the filter would cause considerable problems.No evidence of attempted filter removal has been provided to date.Per a ct abdomen: "filter type: cook gunther tulip.Ivc stenosis: no.Filter position: below above the renal veins.Filter migration: none.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: yes.Impressions: the filter is not tilted but the cone of the filter is against the anterior wall of the ivc.Axial image 36.The anterior strut penetrates 10 mm through the ivc wall.Sagittal image 32.The left strut penetrates 12 mm through the ivc wall.Coronal image 33.The posterior strut penetrates 11 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes.Sagittal image 32.Axial image 46.The right strut penetrates 9 mm through the ivc wall.Coronal image 33".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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: organ perforation.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.A total of 10 devices were manufactured in the reported 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 current 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.

• 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: 11618887
• MDR Text Key: 251088716
• Report Number: 1820334-2021-01075
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2010
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 1869416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2007
• 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
• Patient Sex: Female
• Patient Weight: 77 KG