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

Model Number	G33016
Medical Device Problem Codes	Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Anxiety (2328); Thrombosis/Thrombus (4440)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient allegedly received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2011 via the right common femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging vena cava perforation.Patient notes and further alleges experiencing anxiety, worry, physical limitations, and post filter placement blood clots.Per a computed tomography (ct) abdomen/pelvis: "caval perforation: grade 2 caval penetration at 7 o'clock.Grade 1 caval penetration at 1 o'clock, 4 o'clock and 10 o 'clock.Tilt : yes 7.90 degree left lateral tilt.No ap tilt.Migration: no.Pertinent negatives: see below.Additional findings: location: tip is 1.5 cm below the right renal vein.Number of struts 12.Strut fracture: no".
Additional Manufacturer Narrative
The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2022-00260.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 this initial medwatch report.Occupation: non-healthcare professional investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation, thrombus, tilt, anxiety, worry, fear, and physical limitations.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 anxiety, worry, fear, physical limitations is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 20 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 controls.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.

• 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: 14687288
• Report Number: 1820334-2022-01053
• Device Sequence Number: 4635799
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)140301(10)2688391
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K043509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: 03/01/2014
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2688391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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: Female
• Patient Weight: 104 KG