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 Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Investigation: the following allegations have been investigated: organ/vc perforation, dvt/ivc thrombosis.The reported allegations have been 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.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.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

The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2006.Approximately 2 weeks after implant, the decision was made not to attempt removal of the filter and, approximately 2 weeks after that, the patient was diagnosed with deep vein thrombosis.The patient was also diagnosed with ivc thrombosis approximately 7 months after and again 2 years and 7 months after filter implant.Approximately 9 years and 8 months after filter implant, it was noted prongs of the ivc filter had perforated the vena cava, with 1 prong protruding into a loop of small bowel.Hospital and medical records have been requested, but not yet provided.

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: fear.Unknown if the reported fear is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers 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 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 a filter via the right internal jugular vein due to thrombus.Patient is alleging vena cava perforation, deep vein thrombosis (dvt) and thrombus status post filter placement.Patient notes and further alleges experiencing "fear".Per a ct abdomen and pelvis: "impressions: 1.Enlarged common femoral, external iliac, common iliac, and inferior vena cava veins bilaterally, consistent with thrombus.The inferior vena cava above the level of the ivc filter is normal in appearance.There is marked enlargement of the inferior right renal vein which does not opacify with contrast unlike the superior right renal vein.This is compatible with propagation of thrombus and is a change when compared to the prior examination.Given the history, the thrombus in this patient is likely to be some combination of bland versus tumor thrombus".Per a positron emission tomography (pet): "on ct, thrombus is seen in the iv-c and more inferior veins, which may represent tumor thrombus versus bland thrombus."impression: 3.Multiple vascular collaterals seen in the abdomen and pelvis secondary to inferior vena cava thrombosis below the level of the inferior vena cava filter".Per a ct abdomen: "impression: 1.Stable inferior vena cava filter with intraluminal thrombus within the inferior vena cava as above.2.Poor visualization of the bilateral common iliac veins and bilateral external iliac vein which may be related to chronic occlusion.However, there are multiple collateral vessels in the pelvis and in the left periaortic space".Per a ct chest, abdomen, pelvis: "3.Multiple vascular collaterals seen in the abdomen and pelvis secondary to inferior vena cava thrombosis below the level of the inferior vena cava filter".Per a ct abdomen: "impression: 1.Infrarenal ivc filter with prongs protruding outside of the vessel lumen.The anterior most prong appears to protrude into a loop of small bowel.No secondary signs of bowel perforation".

Event Description

Per additional information received, the patient is additionally alleging stenosis.Ct(2): "findings: filter type: cook.Ivc stenosis: yes.Filter cone position: below the renal veins.Filter migration: no.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: yes.Impressions: the ivc is collapsed around the filter which is consistent with chronic ivc stenosis.The anterior strut penetrates 11 mm through the ivc wall.It penetrates into a loop of bowel.Sagittal image 67.The left strut penetrates 9 mm through the ivc wall.Coronal image 52.The posterior strut penetrates 8 mm through the ivc wall.Sagittal image 67 is a.The right strut penetrates 6 mm through the ivc wall.

Manufacturer Narrative

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: inferior vena cava stenosis.The additional information regarding inferior vena cava stenosis does not change the previous investigation results for deep vein thrombosis/inferior vena cava stenosis.Catalog and lot numbers 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 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: 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: 11886498
• MDR Text Key: 261758432
• Report Number: 1820334-2021-01404
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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
• Date Manufacturer Received: 09/27/2022
• 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: Male
• Patient Weight: 98 KG