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

Catalog Number	IGTCFS-65-FEM
Medical Device Problem Codes	Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Scar Tissue (2060); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2022-00545.Additional information provided determined that this device was manufactured by cook inc (cinc).With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in g8 of this initial medwatch report.Section e3: non-healthcare professional.Investigation the following allegations have been investigated: vena cava (vc) perforation, clot, tilt, pain, internal bleeding, swelling, scarring, limited activity.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: vascular trauma, vena cava perforation, vena cava penetration.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.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.Unknown if the reported pain, internal bleeding, swelling, scarring, and limited activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.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 or Problem Description
Patient allegedly received an implant in (b)(6) 2012 via the unspecified femoral vein due to deep vein thrombosis (dvt).The patient alleges vena cava perforation and tilt.The patient further alleges 4 prongs perforate the inferior vena cava, maximum distance of perforation is 3.63 mm, 4.72-degree tilt superior left to inferior right, limited activity, pain, internal bleeding, swelling, clotting, scarring, and defective foreign object in the body providing reduced or non-existent benefit.On (b)(6) 2019, per a report from computed tomography; ¿positive for caval perforation.Superior extent of ivc filter l3 vertebral body.Inferior extent l4 vertebral body.A total of 4 prongs have perforated through ivc.Maximum distance prongs perforated through ivc 3.63 mm.4.72 degree tilt superior left to inferior right.¿.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Common Device Name: 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: 17596772
• Report Number: 1820334-2023-01129
• Device Sequence Number: 12377009
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)141101(10)2877316
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K043509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2014
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2877316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male
• Patient Weight: 111 KG