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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-1-UNI-CELECT-PT |
| Device Problems
Difficult to Remove (1528); 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); Internal Organ Perforation (1987); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.(b)(4).Summary of investigational findings: the reported allegations have been 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 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.Unknown if the reported pain 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 medical will continue to monitor for similar events.
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Event Description
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Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2016.Hospital and medical records have been requested but not yet provided.On or about (b)(6) 2017 [pt] experienced severe pain in his leg, which required a 3-day hospitalization while on a business trip.During this admission, he was diagnosed and treated for an occlusive thrombus which extended from the mid-femoral vain all the way to the popliteal vein; bilateral pulmonary embolisms; as well as heart strain caused by the aforementioned pulmonary embolisms.On or about (b)(6) 2018, the ivc filter was attempted to be removed from [pt]; this retrieval attempt was unsuccessful.On or about (b)(6) 2019, ct imaging showed at least one ivc filter "arm" perforating outside of the inferior vena cava lumen in [pt].On or about (b)(6) 2019, [pt] underwent his second unsuccessful filter retrieval attempt.Ultimately, [pt] was referred to another hospital for exploration of further surgical removal options, which is ongoing." patient outcome: it is alleged that "as a direct and proximate result of having the ivc filter implanted in him, [pt] has suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] has suffered emotional trauma, harm and injuries that will continue to be so diminished into the future.Furthermore, [pt] has lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters defects.".
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Event Description
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Patient allegedly received an implant via the right common femoral vein due to imminent orthopedic surgery with history of deep vein thrombosis (dvt)/pulmonary embolism (pe).Patient alleges an unsuccessful filter retrieval due to pain on (b)(6) 2018 and on (b)(6) 2019 due to embolism and thrombosis of vena cava.Patient is alleging migration, tilt, vena cava perforation, fracture, device is unable to be retrieved, bleeding, organ perforation, heart strain and pulmonary hypertension, pain, long-term anticoagulation, migration of broken filter piece, sinus surgery due to pulmonary hypertension and medications.Patient notes and further alleges experiencing "easy bruising due to anticoagulation therapy, fear of pe recurrence and death, unable to fly for work or leisure due to high risk of clotting, shortness of breath due to pes and pulmonary htn, and [patient] moved to a lower altitude in order to breath more easily due to his pulmonary hypertension" and diminished physical activity.Per a (b)(6) 2018 unsuccessful filter removal attempt: "then we used the cook filter retrieval sheath system, ensnare and multiple other devices (guide catheters etc) to remove the filter but unfortunately we were not successful to snare the hook with any of the available devices".Per an (b)(6) 2019 computed tomography (ct) abdomen: "impression: 1.One of the infrarenal ivc filter prongs at the 10:00 position projects outside of the ivc lumen coming into very close proximity if not at least partially coursing through the adjacent gonadal vein and transverse duodenum without active bleeding, regional fluid, or pneumoperitoneum to suggest acute perforation".(b)(6) 2019 unsuccessful filter removal attempt: "conclusions: 1.Unsuccessful attempt at removal of ivc filter - filter tethered to ivc wall from hook and legs".
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: fracture, organ perforation, deep vein thrombosis(dvt), migration, tilt, bleeding, heart strain, pulmonary hypertension, long term anticoagulation, sinus surgery, bruising, dyspnea, limited physical activity.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.The additional information regarding deep vein thrombosis does not change the previous investigation results for occlusive thrombus.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 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 bleeding, heart strain, pulmonary hypertension, long term anticoagulation, sinus surgery, bruising, dyspnea, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Twenty (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.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.
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