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

Catalog Number IGTCFS-65-JUG

Device Problems Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); Perforation of Vessels (2135); Depression (2361); Insufficient Information (4580)

Event Type  Injury  

Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2010, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

This is one of two medwatch reports that is associated with this same plaintiff.Occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number 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.

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: organ/vena cava (vc) perforation, tilt, abdominal pain, depression, 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.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 abdominal pain, depression, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.The product 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

Patient allegedly received an implant on (b)(6) 2010 due to deep vein thrombosis (dvt) and abdominal/pelvic surgery.Patient is alleging tilt and vena cava perforation.Patient further alleges stomach pain, physical limitations, and depression.Report from ct (computed tomography): "ivc filter noted with the filter legs extending through the wall of the cava." report from ct: "ivc filter with: tilting with the apex against the ivc wall.3 mm mesenteric perforation.No stenosis, fracture, or migration.".

• 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: 14695951
• MDR Text Key: 294030987
• Report Number: 1820334-2022-01064
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• 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
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 2379456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2009
• 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