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

Model Number G33016

Device Problems Structural Problem (2506); Device Tipped Over (2589); Material Twisted/Bent (2981)

Patient Problems Perforation of Vessels (2135); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook (b)(4) under manufacturer report reference# 3002808486-2020-01046.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference #.Reporter occupation: non-healthcare professional.Investigation: the following allegations have been investigated: vena cava perforation, tilt, bent, anxiety/worry/ptsd.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 bent, anxiety/worry/ptsd are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) devices were manufactured in the reported 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 medwatch report will be submitted if additional relevant information becomes available.

Event Description

The patient received an implant on (b)(6) 2013 via the right common femoral vein due to multiple pulmonary embolisms and deep vein thrombosis.The patient alleges tilt, vena cava perforation, and perforation abutting other organs.The patient further alleges anxiety, worry, and ptsd.On (b)(6) 2018, per a report from computed tomography; ¿ivc filter evaluation: a celect type filter is suggested.Filter tilt: the filter tip is tilted toward the right approximately 6 degrees.There is also significant tilting of the filter tip anteriorly at 16 degrees and the tip is abutting the anterior wall of the ivc at about the 11:00 position.Ivc filter position: filter position is not optimal.The tip of the filter is located 6mm beyond the inferior wall of the right renal vein and 6mm on the inferior wall of the left renal vein.The renal veins are at about the same position.Filter perforation: filter strut perforation is seen at the 2:00 position and separated from the ivc wall by 2mm and abutting and perhaps penetrating the posterior wall of the duodenum, third position.Filter strut perforation is seen at he 4:00 position and separated from the ivc wall by 3mm and abutting the anterior cortex of the l2 vertebral body inferiorly near the l2-3 disc space.Filter strut perforation is seen at the 7:00 position and separated from the ivc wall by 2mm.This abuts the anteromedial right psoas muscle.Filter strut perforation is seen at the 9 to 10:00 position and separated from the ivc wall by no more than 1mm and is not abutting any structure.Filter strut fracture or bending: there is no filter strut fracture identified.The filter strut shown at the 9 to 10:00 position shows some very minimal bending.Ivc stenosis: there is no ivc stenosis identified.¿.

• 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
• 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: 11279677
• MDR Text Key: 230453292
• Report Number: 1820334-2021-00250
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)160501(10)4286806
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 4286806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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 Weight: 142