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

Model Number	G33017
Medical Device Problem Codes	Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Codes	Abdominal Pain (1685); Chest Pain (1776); Pain (1994); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient allegedly received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2013 via the right internal jugular vein due to diagnosed with deep vein thrombosis (dvt)/pulmonary embolism (pe).Approximately 6 years and 6 months later the patient had a computed tomography scan of the abdomen and pelvis, which revealed the filter left a grade 3 perforation with a strut extending 5mm outside the cava wall and embedded in the left lateral wall of the aorta.The filter has also migrated 24mm.The patient had no indication that the filter caused their abdominal and lower back pain.The patient has endured physical pain and suffering, mental anguish, loss of enjoyment of life, and other losses, some of which are permanent in nature.The patient alleges device migration, tilt, vena cava perforation, and unable to be retrieved.The patient further alleges chest/neck pain.
Additional Manufacturer Narrative
The previous medwatch report was submitted by william cook (b)(4) under manufacturer report reference# 3002808486-2022-00151.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 # in this medwatch report.Investigation: the following allegations have been investigated: vc/aorta perforation, embedded, unable to remove, migration, tilt, abdominal/back/neck/chest pain, mental anguish, loss of enjoyment of life.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.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).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.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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 abdominal, back, neck, chest pain, mental anguish, and loss of enjoyment of life 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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.

• Brand Name: GUNTHER TULIP JUGULAR 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: 14134962
• Report Number: 1820334-2022-00598
• Device Sequence Number: 19869098
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)160201(10)4137762
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K072240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 04/18/2022

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: 02/01/2016
• Device Model Number: G33017
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 4137762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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: 102 KG