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

Model Number	G33016
Medical Device Problem Codes	Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506)
Health Effect - Clinical Codes	Stroke/CVA (1770); Internal Organ Perforation (1987); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)
Type of Reportable Event	Death
Event or Problem Description
The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2010 to prevent blood clots.The following is alleged: death, stroke, vena cava and organ perforation, blood clots, and device is unable to be retrieved.It is noted and further alleged, the patient experienced poor general health due to the filter.Approximately 11 years and 3 months after receiving the filter implant, the patient underwent a computed tomography (ct) scan and the imaging from this scan showed that the legs of the patient's filter had penetrated the ivc.The scan also showed that the filter legs had "gone into" the patient's pancreas, duodenum, and were also near the renal vein.The patient expired about a month after the aforementioned ct scan.The death certificate lists intracerebral hemorrhage, chronic anticoagulation, and deep venous thrombosis (dvt) as the causes of death.Wrongful death is alleged by the patient's estate.Per the death certificate: cause of death: intracerebral hemorrhage; chronic anticoagulation; deep venous thrombosis.Other significant conditions contributing to death: traumatic brain injury; osteomyelitis.
Additional Manufacturer Narrative
The previous mdr was submitted by william cook europe under manufacturer report reference number (b)(4).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.Blank fields on this form indicate the information is unknown or unavailable.E3 ¿ 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: death, organ/vena cava perforation, deep vein thrombosis (dvt), unable to retrieve, stroke, poor general health.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.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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications the filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Unknown if the reported death, stroke, and poor general health are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) was 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 current 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.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.

• 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: 20051069
• Report Number: 1820334-2024-01101
• Device Sequence Number: 8043865
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)120801(10)2374443RX
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K043509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 08/22/2024

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: 08/01/2012
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2374443RX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2009
• 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; Death
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White