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

Catalog Number IGTCFS-65-JUG

Device Problems Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problems Dyspnea (1816); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: non-healthcare professional.Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture, organ/ vena cava perforation, embedment, and difficult/ inability to remove.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.A total of (b)(4) 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 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.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.

Event Description

The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2006 and underwent a computed tomography (ct) scan, approximately 12 years and 7 months later, which revealed that the patient's ivc had moved since implantation.The imaging from this scan revealed that some of the filter struts had perforated through the ivc wall into the patient's soft tissues as well as l2 vertebra.About 4 months after receiving this ct scan, the patient underwent a complex filter retrieval of the ivc filter and during the retrieval, it was noted that at least one strut of the ivc filter was now fractured and embedded into the spine.Subsequently, the surgeons were unable to retrieve this fractured strut.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

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: tilt, pain, shortness of breath, physical limitations, depression, anxiety, post traumatic stress disorder (ptsd).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, shortness of breath, physical limitations, depression, anxiety, and post traumatic stress disorder (ptsd) are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) 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 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.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received a filter via the right internal jugular vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).Filter retrieval attempts made (b)(6) 2006 were unsuccessful; however, the filter was successfully removed on (b)(6) 2019.Patient is alleging device tilt, vena cava and organ perforation and fracture.Patient notes and further alleges experiencing "chronic pain under ribcage in location of device", shortness of breath, physical limitations, depression, anxiety, possible post traumatic stress disorder.Per the attempted suprarenal filter retrieval: "impression 1.Repeat inferior venacavogram demonstrates a patent inferior vena cava with no residual luminal filling defects to suggest residual clot in the inferior vena cava.2.Suprarenal filter again demonstrated in suprarenal position.Multiple attempts were made to retrieve this filter.However, due to likely endothelialization of the leading hook of the ivc filter, retrieval was unable to be performed".Per the computed tomography (ct) abdomen and pelvis: "clinical history: this patient had dvt and ivc filter placed in (b)(6) 2006 by [physician's name].At that time, [they] had clot within the inferior vena cava as well as symptomatic pulmonary embolus.The suprarenal inferior vena caval filter was placed and angiojet thrombectomy was performed to decrease the clot burden.Removal was attempted or at least considered initially on (b)(6) 2006 but residual thrombus within the inferior vena cava made at an appropriate to remove at that time.The patient returned on (b)(6) 2006 and removal was attempted but the apex of the filter could not be successfully grasped and the filter was left in place"."impression: inferior vena caval filter in place.Leg penetration is present but is unlikely to be symptomatic.One of the posterior legs does penetrate the l2 vertebral body with some sclerosis around the tip of that leg and if filter removal were attempted, it would likely require fracture of that leg which is unlikely to dislodge from the l2 vertebral body.The inferior vena cava is normal in caliber and widely patent with no visible thrombus either within the filter or peripheral to the filter".Per the successful ivc filter removal report: "impression: technically successful complex retrieval of a chronically embedded, tilted and fractured gunther tulip ivc filter the original fractured strut was extravascular and embedded in the l2 vertebral body and was not able to be retrieved".

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Type of Device: 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: 12240617
• MDR Text Key: 263931828
• Report Number: 1820334-2021-01880
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2008
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 1515131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 68 KG