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

Catalog Number IGTCFS-65-1-FEM-TULIP

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

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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 # is unknown but referred to as gunther tulip.Occupation: non-healthcare professional.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.

Event Description

Original.It is alleged that the patient received a gunther tulip on (b)(6) 2011.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 a gunther tulip filter on (b)(6) 2011 via the right femoral vein due to deep vein thrombosis (dvt).This filter was subsequently removed (b)(6) 2011 without complications.There are no patient allegations against this filter.A second gunther tulip filter was implanted (b)(6) 2011 via the right femoral vein due to post dvt.Patient is alleging device tilt, vena cava and organ perforation.Patient notes and further alleges experiencing physical limitations, worry, fear, anxiety, and stress.Per a ct abdomen without contrast: "inferior vena cava filter is identified in place in correct position with no fracture or migration.Four distal struts are visualized with the most prominent strut perforating posteriorly by approximate 4 mm adjacent to the anterior wall of l3 vertebra.Left lateral tenting is also noticed adjacent to the wall of the abdominal aorta with no signs of perforation." "the inferior vena cava has a caliber within normal limits below and above the level of the ivc filter.".

Manufacturer Narrative

G4: (pma/510k): k172557.Investigation: the following allegations have been investigated: organ/vena cava perforation, tilt, anxiety, worry, stress, fear, physical limitations.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 anxiety, worry, stress, fear, 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.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.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: GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• MDR Report Key: 11547839
• MDR Text Key: 245850820
• Report Number: 3002808486-2021-00995
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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: 04/14/2014
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E2733826
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 112