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| Catalog Number UNKNOWN |
| Device Problems
Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Internal Organ Perforation (1987); Great Vessel Perforation (2152)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Initial reporter occupation: non-healthcare professional.Pma/510(k) k172557.(b)(4).Summary of investigational findings: the following allegations have been investigated: broken strut, inferior vena cava (ivc) perforation, difficult to retrieve, tilt.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.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 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.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 "on or about (b)(6) 2011, [pt] underwent a ct angiogram which demonstrated evidence of bilateral pulmonary emboli, greatest in the lower left lobe.[pt] received a gunther tulip filter on (b)(6) 2011.On or about (b)(6) 2018 [pt] underwent a ct of the abdomen which showed more than one ivc filter ¿arm¿ perforating outside of the inferior vena cava wall in [pt].Specifically, the ct showed: the upper tip of the device was immediately below the bilateral renal vein confluences, a posterior tilt resulting in anterior tine that extended beyond the ivc along the posterior margin of the uncinate process of the pancreas, a probable broken strut fragment along the anterior wall of the third portion of the duodenum about 1.8 cm long between the pancreas and third duodenum, the most anterior long tine extended through the ivc wall along the posterior aspect of the uncinate process of the pancreas and then extended between the pancreas and third portion of the duodenum where there appeared to be a vertical 1.8 cm struct fragment along the anterior wall of the third portion of the duodenum, and the other three long tines of the device had their tips also extending beyond the apparent wall of the ivc"."on or about (b)(6) 2019, [pt] underwent another ct.A final determination was that the ivc filter was overlying the right hemiabdomen, creating a risk of the pancreas being punctured.An operation to remove the filter was deemed high-risk, so rather than remove the filter, doctors instructed [pt] to monitor her abdominal area and, should she exhibit any pain, return to the hospital to be re-evaluated for a removal surgery".Patient outcome: it is alleged that "as a direct and proximate result of having the ivc filter implanted in her, [pt] has suffered permanent and continuous physical injuries, pain and suffering, disability and impairment.[pt] has also suffered emotional trauma, harm and injuries that will continue into the future.[pt] has lost her ability to live a normal life, and will continue to be so diminished into the future".Hospital and medical records have been requested but not yet provided.
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Event Description
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Patient allegedly received an implant on (b)(6) 2011 via the right internal jugular vein due to bilateral pulmonary embolism.The patient alleges migration, tilt, vena cava/organ perforation, filter fracture, and device unable to be retrieved.The patient further alleges perforated pancreas, filter embolization consisting of post-deployment movement of the filer to a distant anatomic site, emotional distress, and limited mobility.Per a report from computed tomography; ¿ivc umbrella filter is noted to be positioned with its upper tip immediately below the bilateral renal vein confluences.It does show a posterior tilt resulting in anterior tine extending beyond the ivc along the posterior margin of the uncinate process of the pancreas and then between the pancreas and third duodenum where there is a probable broken strut fragment along the anterior wall of the third portion of the duodenum about 1.8cm long.No hemorrhage is apparent.No gross ct sign of pancreatitis.¿.
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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: organ perforation, migration, emotional distress, limited mobility.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.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 emotional distress, limited mobility 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.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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Search Alerts/Recalls
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