MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-UNI-TULIP

Device Problems Structural Problem (2506); Device Tipped Over (2589); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Fatigue (1849); Perforation of Vessels (2135); Anxiety (2328); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.Pma/510(k) k172557.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2011.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Event Description

Patient allegedly received an implant prophylactically.Patient is alleging device tilt and vena cava perforation.Patient notes and further alleges experiencing "i have been having pains in my chest and just don't feel well all around and i would love to have this thing removed.I feel like i now have a constant anxiety and severe tiredness and just do not feel well at all".Per a computed tomography (ct) of the abdomen: "an ivc filter is seen within the ivc approximately 3.9 cm distal to the left renal vein connection with the ivc.The apex of the ivc filter is angled anteriorly.Two of the prongs of the ivc filter are proud at the 4 and 6 o'clock axial locations measuring approximately 5 and 3 mm".

Manufacturer Narrative

Investigation: the following allegations have been investigated: vena cava perforation, tilt, chest pain, anxiety, fatigue.Investigation is reopened due to additional information provided.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 chest pain, anxiety, fatigue are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 specifications.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 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: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11228328
• MDR Text Key: 228631571
• Report Number: 3002808486-2021-00050
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2013
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E2666987
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 100