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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); Anxiety (2328); Depression (2361)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Reporter occupation: non-healthcare professional.Summary of investigational findings: the reported allegations have been 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.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) 2008, [pt] was implanted with a cook celect vena cava filter.In (b)(6) 2019, [pt] underwent a computed tomography scan (¿ct scan¿) which revealed his cook ivc filter had fractured and migrated since its implantation.Specifically, several filter struts were perforating [pt]¿s inferior vena cava wall with one filter strut perforating into [pt]¿s vertebra.Further, at least two of the filter struts had fractured and detached from the body of [pt]¿s cook ivc filter." 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.For the rest of his life, [pt] will require ongoing medical care and monitoring.[pt] has also suffered significant, disfiguring injuries, including significant pain and distress restricting his ability to engage in activities of daily living.".
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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, tilt, swelling, pain, inflammation, insomnia, anxiety, depression, physical limitations.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 vena cava perforation.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 swelling, pain, inflammation, insomnia, anxiety, depression, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged celect is manufactured and inspected according to 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 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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Event Description
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Patient allegedly received an implant via the right common femoral vein due to trauma.Patient is alleging device migration, vena cava and organ perforation and fracture.Patient notes and further alleges experiencing "swelling, pain and aches, inflammation [sic], sharp poking pains.Hurts walking, lifting, bending over.There's been many days i couldn't work due to the ivc filter causing very bad pain.Hard to sleep at night from aching pains from ivc filter", physical limitations, anxiety and depression.Per the (b)(6) 2019 computed tomography (ct) abdomen without contrast: " filter tilt: the filter apex is located near the medial wall of the ivc.Migration: ivc filter tip is located less than 2 cm below the lowest renal vein.Perforation: the filter appears to be composed of eight regular size struts and four extra long struts.The eight regular size struts appear to be located within the ivc.The four extra long struts are located at 90° intervals around the circumference of the filter and extend beyond the ivc wall into the surrounding structures.The anterior strut appears fractured and not contiguous with the rest of the filter.The tip of the anterior strut is positioned at the right lateral margin of the superior mesenteric vein 3 cm above the ivc wall.The right side strut tip is positioned between the right ureter and the psoas muscle approximately 1.5 cm beyond the ivc wall.The posterior strut also appears fractured and not contiguous with the rest of the filter.A fragment of the posterior strut measuring partially 1.5 cm in length is located between the spine and the right psoas muscle.A separate fragment measuring approximately 3.5 cm in length is located in the right iliacus muscle adjacent to the right iliac bone.The left side strut is located in the anterior cortex of the l4 vertebral body.Ivc stenosis: no evidence of stenosis".
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Search Alerts/Recalls
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