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WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-JUG-CELECT-PERM |
| Device Problems
Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Pulmonary Embolism (1498); Abdominal Pain (1685); Chest Pain (1776); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect 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 becomes available.
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Event Description
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It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2011, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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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, fracture, vena cava/organ perforation, embedment, dvt, difficult to retrieve, migration, pain, limited mobility, dyspnea, insomnia, worry, fear, depression, anxiety.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.Unknown if the reported pain, limited mobility, dyspnea, insomnia, worry, fear, depression, anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4).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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Patient allegedly received an implant on (b)(6) 2011 due to pulmonary embolism (pe), followed by a failed open retrieval attempt on (b)(6) 2021 and successful percutaneous removal of an intraluminal strut at risk for embolization (b)(6) 2021.The remainder of the filter was left in place.Patient is alleging migration, vena cava/organ perforation, fracture, unable to retrieve (part of fractured filter remains in patient), and deep vein thrombosis (dvt).The patient further alleged experiencing chest pain and pain radiating throughout the body which, at times, was sudden and lasting and resulted in difficulty moving and breathing until the pain subsided.Patient further alleged experiencing they felt as if they had "swallowed a softball".An open-heart procedure was performed to remove part of the ivc filter which proved unsuccessful.Currently, the patient alleges experiencing sudden pain in the abdomen (when bending over) and chest.The abdominal pain allegedly limits physical exertion and the ability to sleep on their left side.The chest pain is described as radiating to the arm, shoulder blades and back of the neck.Patient further alleges feeling "worry and fear" due to the filter remnants in their body and any future issues which may occur, as well as depression and anxiety.On (b)(6) 2020, report from xray: "an ivc filter remains in place within the upper abdomen.A fractured leg of the ivc filter is again identified, measuring 3.5 cm in length and located superior to the remainder of the rim filter at the level of the intrahepatic portion ivc." on (b)(6) 2021, report from xray: "there is a thin metallic wire in a branch of the right pulmonary artery to the right lower lobe, as before.The fractured leg of the ivc filter is again noted in the upper abdomen." on (b)(6) 2021, report from ct 2: "fractured lvc is in place with some of its limbs projecting beyond the border of the ivc.There is an adjacent fracture fragment within the ivc and another fragment inferiorly along the wall of the ivc." "fractured lvc fragments as above.One fragment is located in the right ventricle and projects beyond the myocardium, could be projectional versus myocardial injury.No hemopericardium." on (b)(6) 2021, report from ct: "no thrombotic pulmonary embolism.There is a fractured ivc fragment in a subsegmental right lower lobe pulmonary artery.Heart: there is a fractured ivc fragment in the right ventricle, possibly extending through the right ventricular wall better seen on the abdominal ct.Aorta, thoracic: unremarkable." "fractured ivc fragments in the right ventricle with possible extension through the wall, a subsegmental right pulmonary artery, posterior mediastinum either within or immediately posterior to the posterior wall of left atrium, ivc, andretroperltoneal space.Some of the ivc limbs project beyond the border of the ivc." on (b)(6) 2021, report from xray: "fractured ivc filter is present.Several filter fragments are seen within the upper abdomen as well as projecting over the right ventricle, left hilum, and right segmental pulmonary artery." "impression: fractured ivc with fragments likely within the heart, left hilum, and right segmental pulmonary artery".On (b)(6) 2021, report from xray 2: "the linear density correlating with fractured ivc fragment over the right lower lung is similar to the prior study.Evaluation of the opacity that was previously projected over the heart is limited due to the overlying support devices, though there is a remaining curvilinear opacity that is very similar to the prior exam," on (b)(6) 2021, report from xray: "fractured ivc filter with multiple linear filter fragments seen.Again.Linear filter fragments project over the medlastinum, right lung, and the right abdomen." on (b)(6) 2021, retrieval report (attempted): "procedures performed: 1.Sub-xyphoid window.2.Sternotomy with bicaval cannulation for cardiopulmonary bypass and exploration of the myocardium and pericardial space." "her complaint upon presentation was concern for ivc strut fracture and this was confirmed following imaging with cxr and ct scan.Nearly all the struts of this filter have embolized.The main body of the ivc filter is imbedded in the retrohepatic ivc wall.There are two struts adjacent to this in the ivc.There is a strut in the interventricular septal muscle with apparent involvement of the rv free wall.There is a strut posterior to the la but this is hard to visualize exactly where this strut is.Lastly, there is a strut in the distal sub-segmental right pa." "at this point, i felt that the risk of cutting into heart muscle to retrieve a strut that was apparently imbedded in the septum would be too high- the risk would greatly outweigh the benefit." "vascular surgery evaluated this case for removal of the rpa strut and said that it would not be feasible given its distal location." "unsuccessful wc strut removal.Other embolized struts remain in place." on (b)(6) 2021, report from xray: "curvilinear metallic densities project over the right lung base and the lleart shadow, likely embollc material from a fractured ivc filter." on (b)(6) 2021, report from xray: "tiny curvilinear metallic structure is again noted overlying the right lower lobe, left lower lobe, and mid upper abdomen.An ivc filter is present with tip overlying the right superior aspect of the l1 vertebral body.Patient is status post median sternotomy.The cardiomediastinal silhouette appears within normal limits.The lungs are clear bilaterally.No pleural effusion or pneumothorax".On (b)(6) 2021, retrieval report (successful): "41-year-old female with history of ivc filter placement 10 years ago complicated by fracture and strut embollzation to the heart and pulmonary arteries.Most of the remainder of the filter has penetrated outside of the wall of the ivc; however, there is one intra-luminal strut felt to be at risk for future embolization." "the 5-french pigtail catheter was advanced over the wire into the distal inferior vena cava, and a flush cavogram was performed, demonstrating a patent ivc with no significant clot surrounding the fractured ivc filter.Additionally, it shows that the majority of the fractured ivc filter, including the retrieval hook, remain extraluminal." "intravascular forceps were then advanced through the sheath, and attempts were made to grasp the intraluminal component of the fractured ivc filter as well as the intraluminal filter strut.After multiple attempts, a 25 mm loop snare was advanced through the sheath and was used to capture the intraluminal strut.The sheath was advanced over the strut, and strut was removed.A final cavogram was performed, demonstrating no residual clot in the ivc and no evidence of extravasation.The largely extraluminal ivc filter components remain in place." "impression: fluoroscopic retrieval of an ivc filter strut.The remainder of the ivc filter, which was not removed, is extraluminal and was left in place with extremely low risk of embolization".
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