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Catalog Number UNKNOWN |
Device Problem
Structural Problem (2506)
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Patient Problems
Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Hematuria (2558); Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Manufacturer Narrative
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Customer (person) not provided, information provided by onderlaw, llc.Occupation: non-healthcare professional.Investigation: 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.Rpn/lot is unknown, however, the device is manufactured and inspected according to current controls.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.This report includes information known at this time.A follow up report will be submitted should additional 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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Event Description
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It is alleged that "patient received a cook tulip filter.Patient is alleging filter perforation of organ.Hospital and medical records have not been provided.".
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Event Description
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No additional information has been provided at this time.
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Manufacturer Narrative
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Additional information: investigation: the investigation was reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this 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 the 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.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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Event Description
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Patient allegedly received an implant on (b)(6) 2006 due to a hip replacement, followed by a successful removal on (b)(6) 2020 due to abdominal pain and irritation of surrounding structures.Patient is alleging vena cava perforation, embedment, and hematuria following removal.Patient further alleges stomach and back pain.Report from ct (computed tomography): "aorta/vasculature: normal caliber aorta and iliac vessels.No atherosclerotic change.A tulip delivery to retrievable ivc filter is again identified within the inferior vena cava.There is suggestion of possible perforation of one of the anterior limb of the filter which appears to encroach on the adjacent duodenum." retrieval report (successful): "[patient] has developed abdominal pain and there is concern regarding ivc filter prongs protruding out of ivc wall and irritating the surrounding structures.[patient] now presents for removal of this ivc filter" "this revealed that ivc was widely patent with no flow obstruction and previously placed temporary ivc filter seems to be in good alignment with no significant tilt or migration.Both right and left renal veins also appeared patent." "operative findings: retained old retrievable cook ivc filter.Patent ivc.The filter hook was successfully engaged with snare device from right ij approach and the filter was removed after moderate force inside a 16 f sheath.Follow up venogram showed contained extravasation.This was successfully tamponaded using 22mm balloon left inflated for few minutes.Follow up venogram in various projections showed no evidence of extravasation or perforation.Patient tolerated the procedure well." report from ct: "interval removal of ivc filter since prior examination.".
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Manufacturer Narrative
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The following fields were updated per additional information received: a2, a4, b1, b5, b6, b7, d6b, and h6.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.The following allegations have been investigated: vena cava (vc) perforation, embedment, back/abdominal pain, hematuria, anxiety.The additional information regarding vena cava perforation does not change the previous investigation results for organ perforation.Unknown if the reported back/abdominal pain, hematuria, and anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The catalog # and lot # are unknown, but the filter 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.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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