MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Difficult to Remove (1528); Material Separation (1562)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Event Description

During a filter retrieval procedure on the (b)(6) female patient, with preexisting condition of paraplegic, it was discovered by ct that multiple fractures of the filter strut occurred.Several primary struts were extra vascular protruding into the vertebral body (spine) and the para spinal muscle.The patient was asymptomatic.A complex retrieval was performed successfully; however, two fractured pieces remain in place inside the patient.Information was provided that the device was implanted in 2004 when the patient was (b)(6), and retrieved when the patient was (b)(6).The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, manufacturing instructions, quality control and imaging review of the device was conducted during the investigation.Imaging review: impression.A review of the imaging provided revealed a fractured primary filter leg broken into 2 fragments located at approximately 29 mm caudal to the hook of the filter.Also, two primary filter legs had perforated the ivc, one grade 3 and one grade 2 interaction.Furthermore, there is found a grade 2 possible grade 3 interaction between the ivc wall and the filter hook and the cranial portion of the filter.The exact reason for the filter fracture and/or perforation discovered approx.12 years after filter placement cannot be determined, but it is noted that the patient was asymptomatic at the time of filter retrieval.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Fracture of the wire and filter perforation of the vena cava wall are known risk s associated with use of the device.There is no evidence to suggest that the device was not manufactured according to specifications and no indication that the filter did not perform as intended.Based on the available information, imaging review, and results of the investigation a definitive root cause cannot conclusively be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.

Event Description

It was reported that prior to filter retrieval procedure, computerized tomography (ct) scan results revealed that the filter strut had fractured into multiple pieces.Several primary struts were extravascular protruding into the spinal vertebral body (spine) and the para pinal muscle.The patient was reported to be asymptomatic.At this time.A complex retrieval utilizing endovascular forceps via bronchial and femoral approach subsequently, successfully performed; however, two fractured pieces remained in the patient.Post-procedure the patient required right renal angioplasty due to injury sustained to the right renal artery during retrieval efforts.The patient was last reported to be doing well with right renal artery function recovered.No further information was provided.Following retrieval of the filter an arteriogram demonstrated severe focal stenosis in the midportion of the right renal artery.This was from extensive manipulation utilizing the endobronchial forceps as well as retrieving the actual filter as not only was the hook extravascular initially, but at least 2 primary legs were also extravascular.The arteriogram does not demonstrate extravasation and there was no intimal flap to suggest a dissection.Given the normal initial arteriogram, the focal high-grade stenosis was most consistent with focal arterial spasm due to irritation/miner injury of the vessel during the retrieval process.Per complaint report, angioplasty was performed of the right renal artery, and post angioplasty the degree of stenosis improved from greater than 85% to less than 30%.The complaint report does not state if any less invasive maneuvers were attempted such as intra-arterial nitroglycerin or just waiting to see if the spasm resolved on its own.Nothing on the images provided, or information recorded in the complaint report would be obvious contributing factors to the degree of penetration or filter fracture observed in this case.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5.Reference: farzanegan, f.& wang, s.L.(2017).Inferior vena cava filter with pancreatic penetration and complex retrieval complicated by renal arterial injury.Journal of vascular and interventional radiology, 28(9), p.1306-08.Http://dx.Doi.Org/10.1016/j.Jvir.2017.06.009.The additional information received does not change the findings or conclusion of the previously completed investigation.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

Additional information received 09apr2020.As reported in the literature, a 31-year-old paraplegic female with a history of a motor vehicle accident, left nephrectomy, and thoracic spinal cord transection presented for evaluation of an unspecified gunther tulip inferior vena cava (ivc) filter.The filter was placed twelve years prior for pulmonary embolism prophylaxis; however, there was no history of deep vein thrombosis.The patient presented with abdominal pain, a fractured filter leg on computed tomography (ct) scan, and concerns regarding the device.Retrieval of the filter was planned.A ct scan found that the apical hook and conical tip of the filter had penetrated across the ivc and was embedded into the pancreatic head between the common bile duct and pancreatic duct.The medial leg of the filter extended into the aortic wall, and the anterior leg was abutting/penetrating the duodenum.The posterior leg of the filter had fractured and had penetrated a vertebral body with visible bone remodeling noted.Aortic angiography was performed prior to filter manipulation.Another manufacturer¿s forceps were inserted into a 16 french cook performer sheath via the right jugular vein.The cranial-most intraluminal aspect of the filter was engaged.A second set of forceps were introduced via the right common femoral vein and used to stabilize the medial leg of the filter to avoid aortic injury.Rotational and caudal forces were directed on the internal jugular forceps to free the filter hook from the pancreas.When the filter tip was in an intraluminal position, it was retrieved into the sheath and after several sheathing attempts, was freed from the ivc and retrieved.The extraluminal fractured leg that was integrated into the vertebral body was left in place, as previously planned.Following retrieval of the filter, an aortic angiogram demonstrated no evidence of aortic injury; however, the midsegment of the right renal artery was severely stenosed.The stenosis was not present prior to the procedure or during the angiogram performed at the beginning of the procedure.The artery was accessed, and a 6 french cook ansel sheath was placed at the ostium of the right renal artery.Two-hundred micrograms of nitroglycerin was slowly infused into the artery without improvement of stenosis.Angioplasty was then performed with another manufacturer¿s balloon.Post angioplasty, an angiogram found significant improvement in the area of stenosis, with only mild, non-flow-limiting residual stenosis remaining.No further intervention was performed at that time.A one-month follow up ct angiogram demonstrated complete resolution of right renal artery stenosis.No further intervention was required.The authors state that review of the pre-procedural ct scan demonstrated close proximity of the right renal artery to the ivc filter cone.The authors hypothesize that the renal artery was injured during the rotational and caudally-directed manipulation of the filter with the forceps.Reference: farzanegan, f.& wang, s.L.(2017).Inferior vena cava filter with pancreatic penetration and complex retrieval complicated by renal arterial injury.Journal of vascular and interventional radiology, 28(9), p.1306-08.Http://dx.Doi.Org/10.1016/j.Jvir.2017.06.009.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5825395
• MDR Text Key: 50517632
• Report Number: 1820334-2016-00666
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided; 04/09/2020
• Supplement Dates FDA Received: 06/07/2017; 05/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR