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Catalog Number UNKNOWN |
Device Problem
Device Tipped Over (2589)
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Patient Problems
Dyspnea (1816); Tachycardia (2095); Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Reporter occupation: non-healthcare professional.Investigation: the reported allegations have been investigated based on the information provided to date.The following allegation has been investigated: tilt.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 # and lot # are unknown.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.
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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) 2008, and tilt of the filter was noted approximately 10 years and 8 months after receiving the implant.It was also first noted during this time that the apex of the filter was in contact with the right lateral wall of the ivc.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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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: tachycardia, dyspnea, physical limitations.Unknown if the reported tachycardia, dyspnea, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown.The product 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 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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Patient allegedly received an implant on (b)(6) 2008 via the right internal jugular vein due to pulmonary embolism (pe).Patient is alleging tilt.Report from ct: "infrarenal ivc filter, located 2 cm below the takeoff of the main renal veins.The apex of the filter is in contact with the right lateral wall of the ivc.".
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Search Alerts/Recalls
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