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

Catalog Number IGTCFS-65-FEM

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); Anxiety (2328); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

It is alleged that the patient received a gunther tulip on (b)(6) 2006.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

Patient allegedly received an implant via the right femoral vein due to pulmonary embolism.Patient is alleging tilt and vena cava perforation.Patient further alleges stress, anxiety and physical limitations.Report from computerized tomography (ct): "a tent-shaped inferior vena cava (ivc) filter is identified with the head tilted to the left reaching the level of the left renal vein above the level of the right renal vein.The angle of the ivc filter relative to the inferior vena ca va is 18 degree.Notice the inferior vena cava angulation relative to the ivc filter become-s-worse above the level of the renal veins relative to the ivc filter become-s-worse above the level of the renal veins (coronal images).There are four distal prongs perforating through the wall.This is most prominent in the posterior lateral by approximately 5.4 mm beyond the wall of the ivc.Posterior perforating prong is approximately 5.3 mm beyond the lumen of the ivc.The anterolateral to the right is perforating by approximately 5.4 mm, and less prominent in the left anterolateral.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.Additional information: investigation.Investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava (vc) perforation, tilt, stress, anxiety, physical limitations.The reported allegations have been further 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.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 stress, anxiety, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 become 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: 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
• MDR Report Key: 9727183
• MDR Text Key: 180161656
• Report Number: 1820334-2020-00402
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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 Expiration Date: 09/01/2009
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 1776150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 132