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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); 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); Pain (1994); Great Vessel Perforation (2152); Anxiety (2328); Distress (2329); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Foreign Body Embolism (4439)
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Event Type
Injury
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Manufacturer Narrative
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Initial reporter occupation: non-healthcare professional investigation: the following allegations have been investigated: fracture (retained fragments) organ perforation, complex removal, tilt, pain (back), disfiguring injuries, distress, limits to adl.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).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.Unknown if the reported pain (back), disfiguring injuries, distress, and limits to activities of daily living (adl) 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 filter 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 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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The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2010.Approximately eleven months later, the patient was to have the filter removed but was informed that the filter's alignment posed too high of a risk for removing it.About eight years and seven months later, after alleging significant back pain, an x-ray found a fractured ivc filter with fragments in the retroperitoneum, renal artery, and kidney.About three months after, another x-ray revealed an additional piece of the filter had fractured and traveled into the lung.Around that time, the patient underwent surgery to remove the filter and the fragments from the lung.However, the other two fragments were not able to be removed.The patient further alleges disfiguring injuries, pain, distress, and restrictions in performing activities of daily living (adl).Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b5, annex g, annex b, annex c, annex d, and h6.Investigation the following allegations have been investigated: fracture (retained fragments) organ perforation, complex removal, tilt, pain (back), disfiguring injuries, distress, limits to adl.Investigation is reopened due to additional information provided.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).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.Unknown if the reported pain (back), disfiguring injuries, distress, and limits to activities of daily living (adl) 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 filter 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 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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Additional information received noted that the patient was implanted with a celect filter.
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Event Description
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Patient allegedly received the celect filter via the right common femoral vein due to history of deep vein thrombosis (dvt) with impending surgery (per medical records).(b)(6) 2020, per a report from computed tomography; ¿an ivc filter is noted.There are displaced fragments of the filter displaced posteriorly and toward the right.There is also a calcification in the right upper quadrant, likely representing a gallstone.¿ (b)(6) 2020, per a report from retrieval report (successful); "in spite of a dedicated attempt, the fractured and embolized filter leg which appears to be at least partially in the right renal vein could not be removed"."a noncontrast ct was then performed because of the penetration of one of the filter legs into the aorta seen on preoperative imaging"."upon inspection of the removed filter and fragments, all of the components were accounted for, noting that the filter leg in the right kidney and partial leg in the vertebral body were retained.Ct scan after removal shows no significant abnormality, specifically no pericaval or periaortic hematoma".¿findings: ultrasound shows an anechoic and compressible right internal jugular vein.Tip embedded celect ivc filter, fractured with one arm retained locally in the ivc, one arm and one leg in the right kidney, at least partially intravascular, one arm fractured and embolized to the right middle lobe pulmonary artery, and one leg fractured and embedded in the adjacent vertebral body in an extravascular position inaccessible to endovascular removal.Impression: successful complex filter removal using jaws of life technique.Successful pulmonary artery and renal vein foreign body retrieval system.Two retained fragments.¿.
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Manufacturer Narrative
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Investigation: the following allegations have been investigated: aorta perforation, embedded, migration.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 aorta perforation and embedded does not change the previous investigation results for organ 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.Catalog number and lot number are unknown; however, the alleged filter 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 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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Manufacturer Narrative
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Investigation: the following allegations have been investigated: fear, anxiety.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported fear and anxiety 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 filter 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 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) 2010 due to history of deep vein thrombosis (dvt) and post-surgery immobility.The patient alleges fear, anxiety, and complex filter retrieval on (b)(6) 2020 due to fracture, tip embedded, and embolized celect filter fragments.
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Search Alerts/Recalls
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