MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET

Model Number	G21360
Medical Device Problem Codes	Obstruction of Flow (2423); Device Tipped Over (2589)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2021-01427.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 # referenced in g8 of this initial medwatch report.Occupation: non-healthcare professional.The following allegations have been investigated: occlusion, tilt, pain, mental anguish, emotional distress, physical impairment, fear, limited physical activity.The reported allegations have been further investigated based on the information provided to date.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.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 pain, mental anguish, emotional distress, physical impairment, fear, limited physical is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 10 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 become available.
Event or Problem Description
Patient allegedly received an implant on (b)(6) 2011 prophylactically.Patient is alleging tilt and occlusion.Patient further alleges "the cook gunter tulip filter remains in [patient's] body.[patient] has experienced physical pain, mental anguish, emotional distress and physical impairment in the past and these issues continue as [patient] fears that the filter may fracture, migrate and perforate other organs and cause serious injury or death.[patient] further states that the ivc filter is clogged." patient can no longer engage in "daily exercise, i¿m out of breath when walking." per bilateral venogram report, "common femoral vein is 100% occluded and has a very small channel leading to the ivc." "conclusion: bilateral cto of common femoral vein.Total occlusion of ivc filter".

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• 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: 13483438
• Report Number: 1820334-2022-00185
• Device Sequence Number: 19956517
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)130201(10)2689801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 02/08/2022

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: 02/01/2013
• Device Model Number: G21360
• Device Catalogue Number: IGTCFS-65-UNI
• Device Lot Number: 2689801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2011
• 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