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

Catalog Number IGTCFS-80-JUG

Device Problems Obstruction of Flow (2423); Structural Problem (2506)

Patient Problems Occlusion (1984); Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Anxiety (2328); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Customer (person) not provided, information provided by (b)(6).Occupation: non-healthcare professional.Investigation: 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.

Event Description

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

Manufacturer Narrative

This medwatch report is related to the same patient information that was submitted for a separate event under manufacturer report number 1820334-2022-01449.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: investigation.The investigation was 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 and post-implant clots.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: 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 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 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

Additional information received alleges that the patient's filter perforated through the inferior vena cava (ivc), abutting other structures.This is the first, lower filter that was implanted within the patient.The patient also had a second, higher filter that was implanted.The patient has subsequently expired, and there are no allegations of wrongful death at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a4, b5, b6, b7, h6 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, ivc stenosis, anxiety, worry, fear, limited physical activity.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.The additional information regarding inferior vena cava stenosis does not change the previous investigation results for post implant clots.Unknown if the reported anxiety, worry, fear, and limited physical activity 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 allegations include "[patient] lived with the anxiety of having two filters that could fail further at any time, but that could not be retrieved without a serious surgery.[patient] worried because [the] filters had perforated outside [the] vena cava, with one of them abutting another structure"."for fear of aggravating [patient's] condition and causing potential future injuries related to the cook filter, [patient] tried not to engage in any activities that could cause [patient] to exert [themselves]".Patient reportedly expired (b)(6) 2020 without allegation of wrongful death.Per a (b)(6) 2019 computed tomography (ct) abdomen/pelvis (infrarenal filter): "filter 2: perforation: yes.Grade 3 perforation of 5 o'clock strut into l3.Grade 2 perforation of 7 o'clock strut 0.52 cm.Grade 1 perforation of the other legs.Tilt: no substantial tilt.Apex of filter does not touch wall of ivc.Migration: unknown.Apex of filter is at level of renal vein confluence.Pertinent negatives: no definite fractured or missing struts seen.Additional findings: ivc appears stenotic as do the common iliac veins".Per the certificate of death: "cause of death: hemorrhagic shock, coagulopathy, mass of colon".

• Brand Name: GUNTHER TULIP JUGULAR 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: 11390288
• MDR Text Key: 233975085
• Report Number: 1820334-2021-00674
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2008
• Device Catalogue Number: IGTCFS-80-JUG
• Device Lot Number: 1499290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2005
• 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: 109 KG