MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52914

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506)

Patient Problems Asthma (1726); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440); Peripheral Edema (4578)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: the reported allegations have been investigated based on the information provided to date.The following allegations have been investigated: thromboses, inability to retrieve, blood transfusion, lower limb edema, pain, redness, tingling, decreased circulation, peripheral neuropathy, nerve damage, anxiety, depression, asthma, limitations on physical activity.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.Unknown if the reported blood transfusion, lower limb edema, pain, redness, tingling, decreased circulation, peripheral neuropathy, nerve damage, anxiety, depression, asthma, limitations on physical activity is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in 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.

Event Description

Patient allegedly received an implant on (b)(6) 2010 due to shortness of breath (sob).Patient is alleging inability to retrieve the device (1 filter retrieval attempt (b)(6) 2020, 1 filter retrieval attempt (b)(6) 2020 "ivc filter crushed"), multiple thromboses (lower limb), and blood transfusion after retrieval.The patient is further alleging lower limb edema, pain, redness, tingling, decreased circulation, peripheral neuropathy, nerve damage, anxiety, depression, asthma, and limitations on physical activity (running, walking, squatting, bending, heavy lifting, climbing, cannot sit with legs in dependent position, standing).

Event Description

Per an unsuccessful percutaneous filter retrieval attempt: "next, attempt was made to retrieve the ivc filter with the bard snare and this was unsuccessful".The hook was found to be embedded and could not be successfully engaged with the snare"."findings: venography revealed both the right common and external and left common and left external iliac veins to be occluded.There was no flow in the inferior vena cava from below.However, with selective venogram at the level of the ivc filter there was thrombus present but some flow.The right common femoral vein had severe stenosis.Also, the left common femoral vein had some disease present, but was grossly patent.After intervention, the right common external and common femoral veins were patent, but there was very slow flow secondary to poor outflow and possible poor inflow.After intervention to the left side, the left common iliac vein and external iliac vein and common femoral vein were also patent.There was residual thrombus within the ivc filter.Impression: 1.Successful recanalization of the right iliac venous system and left iliac venous system.2.Residual thrombus within the ivc filter.3.Unsuccessful attempt of ivc retrieval"."[patient] will need complex ivc filter retrieval with a large bore sheath from the right ij.I think this would be best done with general anesthesia.At that time, the patient may need further intervention of the iliac veins and possible common femoral veins, especially of the inferior vena cava where the filter is located".Per an unsuccessful filter retrieval: ".The patient was brought to the cdl suite and placed supine on the table where general endotracheal anesthesia was induced without incident"."next, rheolytic thrombectomy of the bilateral common femoral vein, external iliac vein and common iliac veins as well as the ivc was performed with angiojet.A venogram was obtained on both sides.Following thrombectomy, attention was then turned to the right neck were 6 french sheath was upgraded to a 20 french sheath after pre-dilating with a 12 french sheath.The sheath was advanced into the ivc.An im catheter and stiff angled glide wire were used to get around the filter"."it was noted that the wire was around one particular limb of the filter so multiple attempts were made again to try to get around the main body of the filter without success.The decision was made to abort trying to retrieve the filter after multiple unsuccessful attempts and stent up through the ivc filter"."findings: 1.Occluded bilateral external and common iliac vein stents with acute thrombus.There was also noted to be chronic thrombus in the ivc filter which severely limited the ability to remove the filter and flow.Severely sclerotic bilateral common femoral veins.Following stenting, the left side demonstrated brisk venous return into the ivc while the right side remained sluggish".Per undated medical opinion of patient imaging (ct dated (b)(6) 2020): "ivc filter is infrarenal in position.The filter is placed just above the bilateral iliac vein stents.There is a hyperechoic stent seen in bilateral iliac veins extending up to the common iliac vein and below the ivc filter (image 1).There is no tilt of the ivc filter.No ivc filter fracture was noted.

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: embedded.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: vascular trauma, vena cava perforation, vena cava penetration.20 devices in lot.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 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.

• Brand Name: COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12636286
• MDR Text Key: 276842736
• Report Number: 3002808486-2021-01876
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529141
• UDI-Public: (01)10827002529141(17)130909(10)E2645890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• 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: 01/25/2023

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: 09/09/2013
• Device Model Number: G52914
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2645890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2010
• 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: 58 KG