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Catalog Number UNKNOWN |
Device Problems
Obstruction of Flow (2423); Structural Problem (2506); Malposition of Device (2616); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135); Weakness (2145); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Catalog# unknown but refered to as a cook celect filter.Occupation: non-healthcare professional (b)(4).Summary of investigational findings: the reported allegations have been investigated based on the information provided to date.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 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 physical injuries, pain and suffering, mental anguish, and disability are 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 or about (b)(6) 2012." it is further alleged that: "on or about (b)(6) 2017, the patient underwent a ct of her abdomen from which it was determined that the filter's struts had penetrated the patients left and renal veins, as well as her abdominal aorta, and that the filter had tilted with the top possibly being embedded in the vein wall." patient outcome: alleged "for the rest of the patients life, she will require on-going medical monitoring and use of anti-coagulants", "[pt] has suffered and will continue to suffer serious physical injuries, pain and suffering, mental anguish, medical expenses, economic loss, loss of enjoyment of life, disability, and other losses".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) 2012 via the right common femoral vein due to post pulmonary embolism.The patient alleges tilt, vena cava perforation, fracture, organ perforation, and embedment.(b)(6) 2017, per a report from computed tomography; ¿an ivc filter is present within the inferior vena cava.The superior tip of the ivc filter is present within the suprarenal ivc.Two of the ivc filter prongs protrude into the right renal vein.One of the prongs protrudes partially within the left renal vein.The distal tips of several of the ivc filter prongs traverse extraluminal to the ivc in the infrarenal region.Within the lower retroperitoneum are several small fracture fragments of the ivc filter, which are best depicted on coronal image #63.¿ (b)(6) 2017, per a report from computed tomography 2; ¿impressions: the filter is tiled to the left.Its proximal cone lies on the wall of the ivc possibly embedded in it.The filter legs have penetrated through the wall of the ivc into the pericaval/mesenteric fat.2 of the secondary support struts penetrate to the right renal vein.One of the secondary support struts on the left penetrates through the left renal vein.One of the secondary support struts on the left penetrates the abdominal aorta.¿.
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Manufacturer Narrative
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Investigation: the following allegations have been investigated: fracture, organ perforation, embedment, loss of enjoyment of life.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.The additional information regarding organ perforation and embedment does not change the previous investigation results for vena cava/aorta and renal vein perforation.Unknown if the reported loss of enjoyment of life is 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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Manufacturer Narrative
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Investigation: the following allegations have been investigated: deep vein thrombosis (dvt), blood clots, leg cramps, loss of leg strength, neuropathy, tiredness, back pain, neck pain, limited mobility, left lung contractions, shortness of breath, discomfort.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.Unknown if the reported leg cramps, loss of leg strength, neuropathy, tiredness, back pain, neck pain, limited mobility, left lung contractions, shortness of breath, 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 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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The patient alleges deep vein thrombosis.The patient further alleges leg cramps, blood clots, loss of leg strength, neuropathy, tiredness, back pain, neck pain, limited mobility, left lung contractions, shortness of breath, and discomfort.
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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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Search Alerts/Recalls
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