Patient allegedly received an implant on (b)(6) 2016 due to recurrent deep vein thrombosis in both legs.Patient alleges abdominal aneurysm, filter in place more than 90 days without further details.Patient further alleges dizziness, vertigo, post implant deep vein thrombosis, fear.It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2016 at (b)(6) medical center; (b)(6) by implanting physician (b)(6).".
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Additional information: investigation ¿ 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 abdominal aneurysm, filter in place more than 90 days, dizziness, vertigo, dvt, and fear are directly related to the filter and unable to identify a corresponding failure mode at this time.The following allegations have been investigated: abdominal aneurysm, filter in place more than 90 days, dizziness, vertigo, dvt, fear.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 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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