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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Thrombosis (2100); Anxiety (2328)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.Summary of investigational findings: the reported allegations have been further investigated based on the information provided to date.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.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 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 will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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) 2009.On or about (b)(6) 2016, [pt] was admitted to hospital with complaints of chest pain and shortness of breath.[pt] subsequently underwent a computer tomography scan (¿ct scan¿) of her chest that revealed the [pt]'s cook celect filter had fractured and migrated since the filter was placed.Specifically, a filter strut had separated from the cook celect filter, migrated, and subsequently perforated [pt]'s left lung where the filter strut lay embedded therein".Patient outcome: it is alleged that "[pt] is at risk for future cook filter fractures, migrations, perforations, and tilting.[pt] faces numerous health risks, including the risk of death".
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: organ perforation, deep vein thrombosis (dvt), unable to remove, bleeding, tight chest, swelling, nausea, vomiting, hand/feet tingling, limited mobility, anxiety, hypertension investigation is reopened due to additional information provided.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 lung perforation.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 bleeding, tight chest, swelling, nausea, vomiting, hand/feet tingling, limited mobility, anxiety, and hypertension are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, the device is manufactured and inspected according to current controls.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.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) 2009 via the right common femoral vein due to post trauma.The patient alleges migration, device is unable to be retrieved, filter fracture, and organ perforation.The patient further alleges intermittent bleeding, tight chest, swelling, nausea, vomiting, hand/feet tingling, deep vein thrombosis on four occasions, limited mobility, anxiety, and hypertension.(b)(6) 2012, per a report from computed tomography; ¿there is an ivc filter in place.The inferior tips of the legs the ivc filter appear to extend beyond the lumen of the inferior vena cava.¿ "addendum: upon further evaluation , a very small amount of localized fluid is suspected within the right upper quadrant.This surrounds a portion of the previously placed inferior vena cava which appears to extend outside of the lumen of the ivc.Sequelae related to ivc placement or perforation cannot be excluded".(b)(6) 2016, per a report from computed tomography; ¿no acute thrombotic pulmonary embolism.Ivc filter leg is seen embolized within a small distal pulmonary artery to the left lower lobe.¿.
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Search Alerts/Recalls
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