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

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problems Inadequate Filtration Process (2308); Structural Problem (2506); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolism (1829); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect platinum filter.Reporter occupation: non-healthcare professional.Pma/510(k) k171712.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2016.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Event Description

Patient allegedly received an implant via the left common femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging device migration, tilt vena cava perforation, fracture and device is unable to be retrieved as well as an unsuccessful percutaneous filter removal due to tilt and embedment of the filter, and a partially successful fragment retrieval due to left ventricular lodgment of a portion of the ruptured filter.Patient notes and further alleges chronic pain, difficulty breathing and physical limitations.Unsuccessful filter retrieval: "venogram revealed widely patent ivc with no thrombus.At this time we then proceeded to attempt to remove the filter.Using a cook retrieval kit, using the stiff 0.035 wire, we exchanged the 5 fr sheath for retrieval set sheath using a dilator.After this with the use of a snare we attempted to retrieve the filter with two different types of snares, it appeared the hook of the filter was slightly tilted and embedded in to the wall of the ivc since the hook of the filter wouldn't move despite multiple-attempts and techniques"."using several endovascular techniques we attempted to move the filter and despite multiple attempts we were unsuccessful"."after all these i felt further attempts would not be feasible and we stopped the procedure".Venogram with attempted ivc filter removal: "patient underwent procedure to remove ivc filter fragment in the left ventricle.Seven mm spider filter wires were deployed in right and left carotid arteries to protect potential fragment emboli to cns.Multiple attempts were made to snare the fragment in the lv but could not grab either ends of the fragment.The ivc filter fragment was stable and did not move with guides and snare around [sic] it.Right radial artery access was closed with tr band.Both femoral artery accesses were closed with perclose.There was no procedural complication.Loss of blood was minimal".Sternotomy, open cardiotomy, retrieval of a portion of the ivc filter: "when removal was attempted, the ivc filter could not be removed and at least 3 pieces of the filter have migrated, 2 in the pulmonary arteries and 1 is found within the confines of the left ventricle.The patient has had recurrent ventricular arrhythmias"."'the left atrium was opened.We looked inside the left ventricle and could not find the wire.We then found a small area of granulation at approximately the junction of p2 and p3 just 4 mm on the left atrial side of the anulus.By digging slightly into this area, we found the end of the wire.This was extracted by pulling on the wire and it was somewhat tight.The granulation area was oversewn with a 4-0 prolene figure-of-eight suture"."chest was closed in the usual manner with stainless steel wire to the sternum, polysorb to the fascia and polysorb to the subcuticular.The patient was taken back to intensive care unit in good condition".

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: fragments embolized, fracture (fx), embedded, difficult to retrieve, migration(fragments), tilt, vena cava (vc) perforation, thrombus, pain, dyspnea, physical limitations.The reported allegations have been further investigated based on the information provided to date.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 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, 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.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.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, dyspnea, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, there is one other complaint 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.

• Brand Name: COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10147092
• MDR Text Key: 196477884
• Report Number: 3002808486-2020-00628
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3231084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 125