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Catalog Number UNKNOWN |
Device Problems
Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)
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Patient Problems
Headache (1880); Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Catalog # is unknown but referred to as celect.Occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.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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It is alleged that the patient received a celect inferior vena cava (ivc) filter in (b)(6) , and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
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Event Description
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Patient allegedly received a cook celect filter in (b)(6) 2013 due to blood clots.Patient is alleging severe migraines.Report from ct (computed tomography): "an inferior vena cava filter is present.The inferior vena cava filter is appropriately positioned with the tip 1.5 cm.Below the lowest visualized right renal vein.The apex of the filter is seen to abut the posterior wall of the ivc resulting in mild posterior tilting of the upper portion.However, there is no significant right to left tilt.No definite evidence for fracture, bending or dislodgement of any of the struts of the filter.No clear fat planes seen between any of the struts and the wall of the ivc filter to definitely suggest perforation beyond the ivc wall.The inferior vena cava is normal in caliber without evidence for stenosis.".
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Manufacturer Narrative
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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: tilt, migraines.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 migraines 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.The product 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 become 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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