Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Device codes: appropriate term/code not available (3191) was selected for the reported device perforation.Investigation: the investigation was reopened due to additional information provided.The following allegations have been investigated: perforation, irritable bowel syndrome, anxiety, back/side pain, and leg cramps.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and 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.Unknown if the reported back/side pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported leg cramps is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported exacerbated ibs is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported anxiety is 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.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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Patient allegedly received an implant on (b)(6) 2010 via the common femoral vein due to lower extremity dvt (deep vein thrombosis).Patient is alleging vena cava perforation and organ perforation.The patient further alleges "i have back and side pain, at times my legs cramp and i have exacerbated ibs.I have anxiety related to the possibility my filter could get worse and/or lead to other injury, up to and including death.".
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