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Catalog Number UNKNOWN |
Device Problems
Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)
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Patient Problems
Abdominal Pain (1685); Dyspnea (1816); Pain (1994); Perforation of Vessels (2135); Intermenstrual Bleeding (2665); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
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Event Type
Injury
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Event Description
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The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2007 and underwent a computerized tomography (ct) scan of the abdomen and pelvis approximately 9 years and 1 month after receiving this implant.At the time [of the ct scan], the patient's physician noted no change in the position of the ivc filter.However, a review of this same ct scan was performed approximately 2 years and 11 months after the scan was performed which revealed that the ivc filter had tilted, causing struts to perforate up to 5 millimeters (mm) beyond the wall of the ivc, with one (1) strut directly adjacent to the abdominal aorta.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Initial reporter occupation: non-healthcare professional.Investigation: the reported allegations have been investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation and tilt.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: vascular trauma, vena cava perforation, vena cava penetration.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.Catalog number and lot number are unknown, however, the alleged tulip 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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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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: embedment, deep vein thrombosis (dvt), tilt, abdominal /back pain, vaginal bleeding, dyspnea, physical limitations.The additional information regarding embedment does not change the previous investigation results for vena cava perforation.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported abdominal/back pain, vaginal bleeding, dyspnea, physical limitations is 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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Event Description
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Patient allegedly received an implant on (b)(6) 2007 via the right common femoral vein due to pulmonary embolism (pe).Patient is alleging tilt, vena cava perforation, and embedment.Patient further alleges "the filter is tilted with multiple strut perforations extending more than 3mm outside the ivc wall.One strut is abutting the abdominal aorta.I often suffer from abdominal pain, back pain, and frequently have 'spotting' and bleeding even outside of my menstrual cycle," as well as dyspnea, physical limitations, and post-implant deep vein thrombosis (dvt).
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Search Alerts/Recalls
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