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Catalog Number UNKNOWN |
Device Problem
Defective Device (2588)
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Patient Problems
Emotional Changes (1831); Pain (1994); Injury (2348); Disability (2371)
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Event Type
malfunction
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Event Description
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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter and as a direct and proximate result of the defect, [pt] has suffered permanent and continuous injuries, pain and suffering, disability and impairment".Additional info requested but not yet provided.
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Manufacturer Narrative
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(b)(4).Investigation still in progress.
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Manufacturer Narrative
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Manufacturer reference: (b)(4).Catalog: unknown but referred to as a cook celect vena cava filter.Expiration date: unknown as lot# is unknown.Since catalog is unknown the 510(k) could be either (b)(4).Investigation still in progress.
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Event Description
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Description of event according to short form complaint filed: it is alleged that " [pt] received a cook celect filter and as a direct and proximate result of the defect, [pt] has suffered permanent and continuous injuries, pain and suffering, disability and impairment".New additional information was provided: a gunther tulip and a cook celect filter were implanted on (b)(6) 2008 at (b)(6) center, (b)(6).Filter was placed at the renal veins enter ivc region t-12, l1 interspace.Filter hook projects over the right l1 pedicle.Attempted gunther tulip retrieval on (b)(6) 2009 by same hospital due to "contraindication to anticoagulation secondary to bleeding fibroids".Alleged migration, vena cava perforation, fracture, device is unable to be retrieved, bleeding.Patient outcome: alleged severe back pain.According to plaintiff "the first symptoms of bodily injuries resulted from the cook inferior vena cava filter was in (b)(6) 2008 and attributed to the cook ivc filter in (b)(6) 2013".
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Manufacturer Narrative
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(b)(4).Catalog: unknown but referred to as a cook celect vena cava filter since catalog is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Summary of investigational findings: no imaging provided and patient's medical record is unknown at this time.Therefore, it is not possible to comment on the alleged migration, vena cava perforation, fracture, device unable to be retrieved and bleeding.Also, it is not possible to comment on the back pain, perm and continuous injuries, pain & suffering, disability & impairment, which patient allegedly suffered as a direct and proximate result of the defect.¿ as to migration under normal conditions, i.E.Ivc < 30 mm, the radial force of the filter will ensure proper attachment of the filter legs to ivc.However, filter migration is a known risk in relation to filter implant reported in the published scientific literature.Ifu, contraindications: megacava (diameter of the ivc > 30mm) ¿ as to perforation published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.¿ fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.¿ filter retrieval is occasionally difficult.Several case reports published in articles, describe successful retrievals of filters by advanced retrieval techniques.Difficult filter retrieval due to embedment of filter legs in the ivc wall is a well-known risk in the literature.Several case reports published in articles, describe successful endovascular retrievals of such filters by advanced retrieval techniques.Rpn and lot# are unknown, but there is 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 cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to short form complaint filed: it is alleged that " [pt] received a cook celect filter and as a direct and proximate result of the defect, [pt] has suffered permanent and continuous injuries, pain and suffering, disability and impairment".New additional information was provided: a gunther tulip and a cook celect filter were implanted on (b)(6) 2008 at (b)(6).Filter was placed at the renal veins enter ivc region t-12, l1 interspace.Filter hook projects over the right l1 pedicle.Attempted gunther tulip retrieval on (b)(6) 2009 by same hospital due to "contraindication to anticoagulation secondary to bleeding fibroids".Alleged migration, vena cava perforation, fracture, device is unable to be retrieved, bleeding.Patient outcome: alleged severe back pain.According to plaintiff "the first symptoms of bodily injuries resulted from the cook inferior vena cava filter was in (b)(6) 2008 and attributed to the cook ivc filter in (b)(6) 2013".
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Manufacturer Narrative
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(b)(4).Mdr follow up3: submitted with information that this complaint will be closed/cancelled due to only a gunther tulip filter is implanted in patient.The gunther tulip filter complaint is covered under (b)(4) and submitted to fda under 1820334-2015-00817.Date of event: unknown as information was not provided.Lot#: unknown as information was not provided.Catalog: unknown but referred to as a cook celect vena cava filter.Expiration date: unknown as lot# is unknown.Since catalog is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Summary of investigational findings: no imaging provided and patient's medical record is unknown at this time.Therefore, it is not possible to comment on the alleged migration, vena cava perforation, fracture, device unable to be retrieved and bleeding.Also, it is not possible to comment on the back pain, perm and continuous injuries, pain and suffering, disability and impairment, which patient allegedly suffered as a direct and proximate result of the defect.As to migration under normal conditions, i.E.Ivc < 30 mm, the radial force of the filter will ensure proper attachment of the filter legs to ivc.However, filter migration is a known risk in relation to filter implant reported in the published scientific literature.Ifu, contraindications: megacava (diameter of the ivc > 30mm) as to perforation published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.Filter retrieval is occasionally difficult.Several case reports published in articles, describe successful retrievals of filters by advanced retrieval techniques.Difficult filter retrieval due to embedment of filter legs in the ivc wall is a well-known risk in the literature.Several case reports published in articles, describe successful endovascular retrievals of such filters by advanced retrieval techniques.Rpn and lot# are unknown, but there is 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 cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to short form complaint filed: it is alleged that " [pt] received a cook celect filter and as a direct and proximate result of the defect, [pt] has suffered permanent and continuous injuries, pain and suffering, disability and impairment".New additional information was provided: a gunther tulip and a cook celect filter were implanted on (b)(6) 2008 at (b)(6) medical center, (b)(6).Filter was placed at the renal veins enter ivc region t-12, l1 interspace.Filter hook projects over the right l1 pedicle.Attempted gunther tulip retrieval on (b)(6) 2009 by same hospital due to "contraindication to anticoagulation secondary to bleeding fibroids".Alleged migration, vena cava perforation, fracture, device is unable to be retrieved, bleeding.On (b)(6) 2016: confirmation received that only gunther tulip filter was implanted in patient.Patient outcome: alleged severe back pain.According to plaintiff "the first symptoms of bodily injuries resulted from the cook inferior vena cava filter was in (b)(6) 2008 and attributed to the cook ivc filter in (b)(6) 2013".
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Search Alerts/Recalls
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