MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Transient Ischemic Attack (2109); Perforation of Vessels (2135); Depression (2361); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2007.Approximately eleven years and 8 months later, it was noted that the prongs of the inferior vena cava (ivc) filter had penetrated the patients ivc, with one prong abutting the aorta and another a small bowel loop.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Non-healthcare professional.Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have 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 numbers are unknown, however, the alleged tulip is manufactured and inspected according to 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.

Event Description

Patient allegedly received an implant on (b)(6) 2007 due to deep vein thrombosis (dvt), followed by a successful percutaneous retrieval on (b)(6) 2019 due to perforation.Patient is alleging vena cava perforation.The patient further alleges "2 tias (transient ischemic attacks), small clots were able to travel to brain causing unbalance, dizziness, swelling [legs]," as well as "sex was very painful," leg swelling, and depression." report from ct: "normal aortic caliber without significant atherosclerosis.Infrarenal ivc filter is present.The prongs extending extraluminally with one prong abutting the aorta and another a small bowel loop on image 43." retrieval report (successful): "ivc cavagram: there is an ivc filter in place with the tip at the l1 -l2 level.The filter is not tilted and the tip is within the caval lumen.There is no filling defect to suggest thrombus within the ivc." "a snare retrieval device was then used to grasp the ivc filter and gently remove it.The filter was removed easily from its position and withdrawn from the body.The filter was examined and found to be intact.The filter was submitted for analysis.A completion cavagram was performed via the 12 fr sheath and demonstrated no thrombus or extravasation.".

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: blood clots/ transient ischemic attacks (tia), depression, pain, dizziness, swelling, imbalance, physical limitations.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.Unknown if the reported depression, pain, dizziness, swelling, imbalance, and physical limitation are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The catalog # and lot # are unknown, but the filter 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

Report from ct (computed tomography): "filter type: cook gunther tulip.Ivc stenosis: no.Filter position: below the level of the renal veins.Filter migration: none.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: no.Impressions: the anterior right strut penetrates 8 mm through the ivc wall.Coronal image 47.The anterior left strut penetrates 9 mm through the ivc wall.Coronal image 45.The posterior right strut penetrates 9 mm through the ivc wall.Sagittal image 70.The posterior left strut penetrates 11 mm through the ivc wall.Sagittal image 74.".

Manufacturer Narrative

Additional information: investigation investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.The catalog # and lot # are unknown, but the filter 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.

• Brand Name: UNKNOWN
• 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: 13543246
• MDR Text Key: 290282729
• Report Number: 1820334-2022-00236
• 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: 02/07/2023

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/09/2022; 01/23/2023
• Supplement Dates FDA Received: 03/31/2022; 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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