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

Catalog Number IGTCFS-65-JUG

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422)

Event Type  Injury  

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 following allegations have been investigated: fracture, organ/vena cava perforation, stenosis, filter blockage, migration, tilt, pain, fear, limited physical activity.The reported allegations have been further investigated based on the information provided to date.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.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 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 pain, fear, limited physical activity is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 19 devices were manufactured in the reported lot.To date, 1 other complaint have been reported against this 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 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.

Event Description

Patient allegedly received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2015, via the right internal jugular vein due to deep vein thrombosis and pulmonary embolism.Patient alleges fracture, vena cava perforation, stenosis, tilt.Patient further alleges ivc filter blockage, pain, fear, limited physical activity.16jul2020, report from ct: "findings: ivc filter is present.It is suprarenal in location.The superior tip of the ivc filter is located 4.4 cm superior to the right renal vein and 7.0 cm superior to the retro aortic left renal vein.The superior tip is located 0.9 cm inferior to the intrahepatic segment of the ivc.There is approximately 4 of anterior tilt of the superior tip of the ivc filter relative to the course of the ivc with the superior tip contacting the anterior wall of the 1vc.Multiple ivc filter struts perforate the ivc.A single left posterior strut extends into the anterior margin of the l2 inferior endplate and into the l2 -l3 disc space.This perforated strut extends 20 mm beyond the confines of the ivc.Posteriorly there is a perforated strut that extends 15 mm beyond the confines of the ivc filter and abuts the l2-l3 disc space without clear perforation into the disc.A left anterolateral perforated strut extends 10 mm beyond the confines of the ivc filter there is a fractured strut entering the right renal vein.A 2nd fractured strut fragment is present within the ivc at the level of the right renal vein.Retroperitoneal surgical clips are present within the aortocaval space and within the right anterior perinephric space.There is stenosis of the ivc inferior to the left renal vein confluence.At this level the ivc measures only 5 mm in ap width.There are numerous collaterals draining veins along the chest and abdominal wall.There is a larger collateral draining vein that appears to arise from the right femoral region measuring up to 14 mm in diameter.It is venous origin is not included within the field of view of this exam.Impression: 1.Ivc filter placement, cephalad migration of the filter.There is perforation of multiple ivc filter struts as well as a fractured strut within the right renal vein and in the ivc at the level of the right renal vein.Additional detail is included above.2.Extensive collateral draining veins within the abdominal and chest wail.Stenosis of the infrarenal ivc.".

• 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: 18282119
• MDR Text Key: 329934963
• Report Number: 1820334-2023-01651
• 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
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 6014762
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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: 60 KG