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Catalog Number UNKNOWN |
Device Problems
Structural Problem (2506); Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).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 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.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 gunther tulip on (b)(6) 2005.It is alleged that 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 an implant on (b)(6) 2015 due to pulmonary embolism (pe) and deep vein thrombosis (dvt).The patient alleges organ perforation.The patient further alleges shortness of breath, chest pain, numbness in extremities, back pain, abdominal pain, and internal discomfort.18jul2019, per a report from computed tomography; ¿impression: infrarenal ivc filter in place.The 4 struts appear to extend outside the ivc.¿.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: organ/vena cava perforation, shortness of breath chest/back, abdominal pain, numbness in extremities, internal discomfort.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.Unknown if the reported shortness of breath, chest/back, abdominal pain, numbness in extremities, internal discomfort are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged tulip is manufactured and inspected according to 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.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.The following fields were updated per additional information received: b5, b6.Investigation: investigation is 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.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Catalog number and lot number are unknown; however, the alleged filter is manufactured and inspected according to 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.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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18jul2019, per a report from computed tomography 3; ¿impressions: the filter is not tilted but the cone of the filter is against the anterior wall of the ivc.The anterior strut penetrates 3 mm through the ivc wall.The left strut penetrates 9 mm through the ivc wall.The posterior strut penetrates 11 mm through the ivc wall.The right strut penetrates 11 mm through the ivc wall.¿.
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Search Alerts/Recalls
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