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

Catalog Number IGTCFS-65-FEM

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Obstruction of Flow (2423); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Thrombus (2101); Perforation of Vessels (2135); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It is alleged that [pt] received a gunther tulip filter on (b)(6) 2010.The patient alleges recurrent blood clots and instances of filter occlusion and filter embedment in tissue.Per additional information received: patient alleges that filter was placed (b)(6) 2010 for the prevention of deep vein thrombosis (dvt).No attempts have been made to remove filter.The inferior vena cava (ivc) appears to be occluded below the level of renal veins.Patient alleges that device is unable to be retrieved, filter/ivc is occluded and post implant blood clot.

Manufacturer Narrative

(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "device is unable to be retrieved, filter/ivc is occluded and post implant blood clot".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging, or venography; this may be symptomatic or asymptomatic.A reference is made to the instructions for use: in potential adverse events are mentioned: â¿¢ damage to the vena cava, â¿¢ pulmonary embolism, â¿¢ filter embolization, â¿¢ vena cava perforation, â¿¢ vena cava occlusion or thrombosis, â¿¢ hematoma at vascular access site, â¿¢ hemorrhage, â¿¢ infection at vascular access site, â¿¢ death.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.

Manufacturer Narrative

Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and 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.Unknown if the reported blood clot is directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.Product is manufactured, inspected and packaged by william cook europe (b)(4).

Event Description

Per abdominal/pelvic ct, dated (b)(6) 2016, "proximal to the filter the ivc is normal in size.At the level of the filter and distal to the filter the ivc is very stenotic.The common iliac veins are also very stenotic, barely visible.The legs of the filter penetrate the ivc wall into the pericaval/mesenteric fat.".

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: stenosis, tilt, painful breathing.The additional information regarding stenosis does not change the previous investigation results for filter/inferior vena cava (ivc) occluded, blood clot.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 painful breathing is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.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 further alleges the occluded filter impacts the patient's chronic obstructive pulmonary disease (copd) causing painful breathing.Per a computed tomography (ct) abdomen/pelvis: "filter type: cook.Ivc stenosis: yes.Filter position: partially above the right renal vein.Filter migration: none.Filter fracture/bending: no.Filter tilt: yes.Filter penetration: no.Other findings: yes.Impressions: the filter cone is 1.7 cm proximal to the right renal vein.The ivc just proximal to the filter is 2 cm in diameter.Just distal to the filter it is 6 mm and both common iliac veins are 2 - 3 mm each.There are innumerable large varicose veins in the abdominal soft tissues secondary to ivc stenosis versus occupation.The filter is tilted such that its proximal cone is against the anterior ivc wall, sagittal image 51.The is an approximately 6 cm long metal foreign body extending from the left common iliac vein to the distal ivc that may represent a collapsed stent, coronal image 35".

• 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 ; 8123392235
• MDR Report Key: 6576944
• MDR Text Key: 75500974
• Report Number: 1820334-2017-01244
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: TX
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2023
• Date Device Manufactured: 04/06/2010
• 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: 92 KG