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

Catalog Number IGTCFS-65-FEM

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)

Patient Problems Nerve Damage (1979); Internal Organ Perforation (1987); Perforation of Vessels (2135); Depression (2361); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.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 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.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2007, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ/ vena cava (vc) perforation, thrombus, device is unable to be retrieved, tilt, nerve damage, limited physical activity, depression.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.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).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 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 nerve damage, limited physical activity, and depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(6) 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 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 an implant on (b)(6) 2007 via the right femoral vein due to bilateral pulmonary emboli (pe) and left leg deep vein thrombosis (dvt) followed by three unsuccessful filter retrieval attempts due to thrombus in filter: (b)(6) 2007.Patient is alleging vena cava perforation, device is unable to be retrieved, tilt, filter will not collapse to be removed, mesenteric perforation.Patient further alleges "i have nerve damage form the attempts to remove the filter," and "limitation on exercising and lifting.If i do too much my nerve pain gets worse from the nerve damage caused by the attempts to remove the filter," as well as depression on (b)(6) 2007: per unsuccessful retrieval report, "the filter is unchanged in position, when compared with the completion cavagram of (b)(6) 2007" "a filling defect is identified within the filter, occupying approximately 1/3 to 1/2 of the volume of the filter.This is consistent with thrombus.Therefore the filter cannot be at this time." on (b)(6) 2007: per unsuccessful retrieval report, "there is a 1.5 cm thrombus identified in the colon of the optional tulip filter.The clot is too large to safely removed the filter." on (b)(6) 2007: per unsuccessful retrieval report, "the filter is unchanged in position, when compared with the completion cavagram of (b)(6) 2007.The tip of the filter is at approximately the level of the l1 superior endplate." "a cavogram demonstrates a filling defect within the superior aspect of the filter, consistent with thrombus.This is decreased volume when compared to the prior study." "after the attempted removal, the filter has not changed in position.The inferior vena cava remains patent.The thrombus has migrated somewhat inferiorly within the filter." "impression: unsuccessful attempted removal of an inferior vena cava filter as described above.This may be related to inability to collapse the filter, due to the presence of organized thrombus versus ingrowth of tissue at the feet of the filter".On (b)(6) 2021: per computed tomography report, "inferior vena cava filter in place, apex of filter mildly tilted to the right, however filter apex not clearly contacting the inferior vena cava wall.There is a single suspected right renal vein, the inferior vena cava filter apex is approximately at the level of the junction of the right renal vein and ivc.There are 2 suspected left renal veins, the filter apex is inferior to the junction of ivc and the more superior left renal vein.There is also an apparent retroaortic left renal vein more inferiorly, with the filter apex approximately 8 mm superior to the junction of the ivc and retroactic left renal vein.All 4 filter struts perforate through the inferior vena cava wall, measuring between approximately 4.5 and 7.5 mm of strut extension beyond the inferior vena cava wall.All four strut perforation appears in close proximity to suspected veins.The left anterior strut perforation comes in close proximity to the duodenum, without frank involvement/ perforation of duodenum.No evidence of aortic, adrenal, pancreatic, renal vein, kidney, psoas muscle, vertebral body or diaphragm perforation by strut.There is no evidence of strut fracture or obvious strut bending.Serosal margin of inferior vena cava does not appear frankly stenotic in vicinity of the inferior vena cava filter.Lack of intravenous contrast limits ability to assess patency of inferior vena cava lumen".

• Brand Name: GUNTHER TULIP FEMORAL 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 ; 8128294891
• MDR Report Key: 13236070
• MDR Text Key: 283764871
• Report Number: 1820334-2022-00045
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2009
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 1773124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2006
• 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: Male
• Patient Weight: 115 KG