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

Model Number G33017

Device Problems Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Perforation of Vessels (2135); Stenosis (2263); Depression (2361); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# (b)(4).Occupation - non-healthcare professional.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 # of this initial medwatch report.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: pulmonary embolism, vena cava perforation, thrombus, stenosis, migration, tilt, pain, depression, anxiety, physical limitations.New pe 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: pulmonary embolism.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.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, depression, anxiety, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) 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.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 become available.

Event Description

Patient allegedly received a gunther tulip filter on (b)(6) 2011 via the right internal jugular vein upon removal of another manufacturer's filter secondary to blood clots above that filter (according to medical records).Patient also received stents in 2010/2011 and (b)(6) 2015.Patient is alleging tilt and vena cava perforation.The patient further alleges "filter movement causing terrible pain and chest shocks.Filter did not prevent blood clots" as well as physical limitations, depression, and anxiety.(b)(6) 2011, report from venogram: "the catheter was then negotiated into the ivc and up through a filter.Contrast injection demonstrated an area of clot above the filter, which seemed to be a [bard] g2 filter.Clot then extended through the filter and down into the entire ivc." "impression: 1.Extensive deep venous thrombosis involving the popliteal vein, superficial femoral vein, common femoral vein, external iliac vein, common iliac vein bilaterally, as well as the ivc and ivc filter into the supra filter ivc.2.Power pulse spray technique was performed bilaterally followed by placement of bilateral ekos infusion catheters for an overnight infusion of tpa, as described above." (b)(6) 2011, report from venogram: "impression: successful thrombolysis of bilateral lower extremity and ivc filter thrombus.Balloon angioplasty of left superficial femoral vein and popliteal vein with restored flow, as well as an unsuccessful angioplasty of the right external iliac vein.There still remains some chronic-appearing stringy thrombus, but this did not seem to be an impediment to flow.Narrowing of the ivc at the level of the filter, which seemed to be the main impediment to flow in the venous system.It was felt that removal of this filter and perhaps balloon angioplasty of the ivc with placement of a new filter higher up might improve flow through the entire venous system." (b)(6) 2011, implant report and retrieval report: ".Guidewire and catheter advanced into the jugular vein.Under fluoroscopic guidance we noted that the patient had an svc filter in place.This was successfully traversed with a glidewire and catheter, which was then advanced down into the svc.Over the wire, the catheter was exchanged out for the filter retrieval sheath.The sheath was advanced into the ivc where contrast injection confirmed narrowing of the ivc at the level of the filter.The filter was then successfully snared with a gooseneck snare and retrieved through the retrieval sheath.Contrast injection now demonstrated a very tight narrowing of the ivc where the filter had previously resided.Over a guidewire, this area was balloon dilated with a 14 mm angioplasty balloon.Contrast injection after angioplasty demonstrated significantly improved luminal caliber." "at this point, we placed a gunther-tulip filter higher up in the ivc, closer to the level of the renal veins." (b)(6) 2011, report from ct (computed tomography): "the ct images through the abdomen and pelvis demonstrate the patient to have a small tear within the inferior vena cava that is seen." "the patient's inferior vena cava filter is noted to have significant thrombus within the nose cone that is causing stenosis to the inferior vena cava.In this hypercoagulable patient, inferior vena cava filter removal should be considered." (b)(6) 2016, report from ct: "patient has inferior vena cava filter and left iliofemoral filter.Filling defects of the right renal vein best appreciated on axial image 63 of series 4 which appears new when compared to prior study.Additionally there is filling defect above the stent best appreciated in coronal image 51 of series 6 which is new when compared to prior study.Collateral circulation is visualized in the abdominal wall secondary to chronic pelvic disease.Suspected thrombus in the right ovarian vein.There is stranding along the left femoral vein which is likely from procedure.Suspected hepatic vein thrombus in the liver." (b)(6) 2017, report from ct: "impression: small nonocclusive pulmonary embolus in a right lower lobe distal segmental pulmonary artery.Large azygos vein in this patient with multiple collateral vessels and history of ivc occlusion.Svc filter in place." "abdominal aorta is normal in caliber.Ivc filter in place.Vascular stent in the ivc as well as left common iliac vein extending to the left femoral vein.The distal aspects of which is not included in the field-of-view.These stents appear occluded, similar to prior examinations." (b)(6) 2017, report from ct: "note of a svc filter with heterogenous density in the svc." (b)(6) 2019, report from ct 2: "there is a left iliac stent in place which extends to the inferior vena cava.There is a separate ivc stent is in place.There is also an ivc filter in place, the cephalic aspect of which is near the level of the renal vasculature.Above the ivc filter, the cava is fairly flat.Numerous varicosities are evident in the upper abdomen similar to the previous examination." (b)(6) 2019, report from ct: "some of the filter struts have penetrated 12mm through the wall of the ivc into the pericaval/mesenteric fat." "the filter is tilted anteriorly with its cone penetrating through the wall of the ivc into the pericaval fat.This may render the filter non removable." "there is a stent in the distal ivc with its proximal end running though the struts of the filter lying proximal to the filter struts.This may allow thrombus distal to the filter to pass through to the pulmonary veins." "the distal ivc is very narrowed likely chronically stenotic or occluded.".

• 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: 11941722
• MDR Text Key: 263368168
• Report Number: 1820334-2021-01465
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)140101(10)2651368
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Model Number: G33017
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 2651368
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2011
• 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 Weight: 91