|
WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
|
Back to Search Results |
|
| Catalog Number IGTCFS-65-FEM-CELECT-PERM |
| Device Problems
Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026)
|
| Patient Problems
Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)
|
|
Event Type
Injury
|
|
Event Description
|
|
It is alleged that the patient received a celect inferior vena cava filter (ivc) on (b)(6) 2011.Approximately 4 months later, the patient underwent initial venography with the intention of removing the filter.But, because venography showed the filter to be slightly tilted with the hook of the filter embedded in the inferior vena cava wall which prevented all ability to remove it, the filter was left in place as a permanent filter.Approximately 10 years later, the celect ivc filter broke and pieces flowed into the patient's bloodstream, including a piece that pierced the heart.The patient experienced immediate pain and discomfort and was immediately evaluated in [hospital] where a broken piece was found in the heart.Patient was transferred to another hospital where, the following day, a physician stopped the bleed and closed the hole.However, the piece in the patient's heart was not able to be removed.It was discovered additional pieces had broken off and traveled throughout the patient's body which the physician could not remove.Approximately one month later an abdominal surgery was performed to remove the pieces; however, there were three pieces which could not be removed - one in the liver, one in the kidney, and one in the spine.Hospital and medical records have been requested but not yet provided.
|
| |
|
Manufacturer Narrative
|
|
Section e3: non-healthcare professional.Investigation: the following allegations have been investigated: fracture, organ perforation, embedment, difficult to retrieve, migration, tilt, bleeding, pain, discomfort.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.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).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.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.Unknown if the reported bleeding, pain, and discomfort 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 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.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.
|
| |
|
Manufacturer Narrative
|
|
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: fracture, organ perforation, embedment, difficult to retrieve, migration, tilt, bleeding, pain, discomfort.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.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 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.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.Unknown if the reported bleeding, pain, and discomfort are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.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.
|
| |
|
Event Description
|
|
Patient allegedly received a celect inferior vena cava filter (ivc) on (b)(6) 2011.
|
| |
|
Event Description
|
|
The patient allegedly received the cook celect filter on (b)(6) 2011 via the right groin due to left common femoral and external iliac vein deep vein thrombosis (dvt).Allegedly, an attempt to retrieve the filter on (b)(6) 2011 was aborted after initial venography revealed the device was tilted and embedded in the vena cava.A second attempt was made via an emergent open sternotomy on (b)(6) 2021 due to filter fracture which was unsuccessful.A third attempt was alleged on (b)(6) 2022 via an open laparotomy due to fracture of ivc filter with pieces embedded in heart, liver, kidney, pancreas, and spine.Patient is alleging device migration, tilt, and inability to be retrieved as well as fracture, bleeding and organ perforation.Patient notes and further alleges experiencing "injury to heart, liver, and spine where filter fragments cannot be removed.Injury to kidney and pancreas by filter fragments.Two (2) major surgical procedures to attempt removal of fragments.Emotional distress, stress , worry, anxiety".Per the retrieval report (attempted): "findings: venogram showing patent inferior vena cava and no evidence of clot at filter base.Filter tilted with hook embedded along the inferior vena caval wall precluding ability to retrieve".Per the report from computed tomography (ct): "impression: no pulmonary embolus.Moderate size pericardia! effusion that has density increase that of simple fluid and may represent some hemorrhage in the pericardia! space.Also along the under surface of the left ventricle in the pericardia! space is a linear radiopaque density.Given that there is a partially imaged ivc filter in the appearance of this entity this would be concerning for a fractured filter leg that has made its way either through the cardiac chamber into the pericardia! space seems most likely".Per a report from x-ray: "none noticed on initial review of this study given the small size but there is a linear radiopaque density that overlies the left heart and the stomach bubble on the radiograph.The appearance especially when viewed with the follow-up chest ct could be indicative of a fractured ivc filter leg".Per a report from x-ray: "findings/impression: fractured limb of the ivc filter overlies l3.Linear hyperdensity overlies the right hemiabdomen, correlate clinically.Recommend repeat abdominal radiograph".Per a report from ct: "addendum: the.Appears that the small linear density in the inferior pericardium on the previous study shifted in position into the posterior left pericardial recess near the pulmonary veins"."findings: ct chest: sternotomy changes are present and there is air and increased density in the anterior mediastinum.Small amount of pericardia! air present.The metallic density on the prior ct in the pericardium has been removed"."ct abdomen: ivc filter sideways within the ivc and some of the limbs project superiorly and toward the left in the region of the head of the pancreas, detail limited without intravenous contrast".Per a report from ct: "findings: the filter leg that was along the undersurface of the heart is no longer present at that location.There is what appears to be an ivc filter leg that is posterior to the left atrium on the left for instance axial image 46 and coronal image 47 and probably best depicted on the sagittal image 50.Uncertain if this is a new component of a fracture filter legs or migration of the initial filter leg seen on prior preoperative ct.Alternatively this conceivably could be suture material although the linear aspect of it favors against suture material.There is no additional filter legs seen in the chest"."there is also a filter leg within the inferior right hepatic lobe segment 5/6 that is similar to the recent ct.The abnormally positioned ivc filter the head appears to extend laterally into the right renal vein orifice.There is what appears to be a fracture filter leg that is not within a vessel but rather at the region of the pancreatic head or just superior to this.Additional filter legs extend outside of the ivc along the anterior margin of the aorta with otherwise normal contour of the aorta at the level of the renal vein for instance.There are filter legs that project posteriorly and appear to be within the l3 vertebra through the anterior cortex.There are no filter legs seen inferior to this".Per a report from x-ray2: "impression: along the left heart border is a linear radiopaque density that is uncertain if this represents suture material during sternotomy in this location or another component of the fractured ivc filter".Per a report from x-ray: "there is an inferior vena cava filter in place with multiple fractures in the film.Magnified views there appears to be small curvilinear metal density in the left hilum that was present on the earlier film.Impression: the questionable thin curvilinear area of metal in the left hilum is once again identified on this examination and is likely reflective of a portion of the fractured ivc filter embedded in the left hilum".
|
| |
|
Manufacturer Narrative
|
|
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: vena cava perforation, emotional distress, stress , worry, and anxiety.The additional information regarding vena cava perforation does not change the previous investigation results for organ perforation/embedment.Unknown if the reported emotional distress, stress, worry, and anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.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.
|
| |
|
Search Alerts/Recalls
|
|
|
