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Catalog Number UNKNOWN |
Device Problems
Structural Problem (2506); Detachment of Device or Device Component (2907)
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Patient Problems
Perforation of Vessels (2135); Anxiety (2328)
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Event Type
Injury
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Manufacturer Narrative
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Catalog # is unknown but referred to as celect.Occupation: non-healthcare professional.Investigation: the following allegations have been investigated: fracture, vena cava/organ perforation.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.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.
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Event Description
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The following information is alleged: the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2011.Multiple struts of the filter have perforated the ivc and struts abut the l3-4 disc space and l4 vertebral body.In addition, a strut of of the filter has fractured.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: anxiety, fear, worry, and physical limitations.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: anxiety, fear, worry, and physical limitations.Unknown if the reported anxiety, fear, worry, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot number are unknown.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 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 on (b)(6) 2011 via the right femoral vein due to a motorcycle accident.Patient is alleging fracture, organ and vena cava perforation.Patient further alleges "i live with the anxiety of having a filter that could fail further at any time, but that cannot be retrieved without a serious surgery.I am worried because my filter has fractured and perforated through my vena cava and into adjacent structures." "for fear of aggravating my current condition and causing potential future injuries related to the cook ivc filter implantation, i try not to engage in any activities that cause me to exert myself.".
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Search Alerts/Recalls
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