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Catalog Number UNKNOWN |
Device Problems
Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589); Insufficient Information (3190)
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Patient Problems
Internal Organ Perforation (1987); Perforation of Vessels (2135); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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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 # is unknown but referred to as celect.Reporter occupation: non-healthcare professional.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.
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Event Description
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Original: it is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2011.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) 2011 via the right common femoral vein due to deep vein thrombosis.Patient is alleging vena cava perforation, device is unable to be retrieved.Patient further alleges fear.Report from computerized tomography (ct): "there is an inferior vena caval filter opposite l2 on the right the lower prongs extend outside the lumen of the inferior cava wall and there is no surrounding hemorrhage.There is no prolonged into the aorta".
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Manufacturer Narrative
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Additional information: investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava (vc) perforation, inability to retrieve, fear.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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Unknown if the reported fear is 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; however, there is 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.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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Manufacturer Narrative
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The following fields were updated per additional information received: b1, b2, b5, b6, annex e, annex a, annex g, annex b, annex c, annex d, and h6.Investigation the following allegations have been investigated: organ perforation, tilt.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.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 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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Per a report from computed tomography 2; ¿the filter is tilted anteriorly and its cone is against the ivc wall.The right side filter leg perforates 16 mm through the ivc wall and perforates into the duodenum.The left side filter leg perforates 18 mm through the ivc wall and penetrates into an intervertebral disc.The anterior filter leg perforates 14 mm through the ivc wall.The posterior filter leg perforates 12 mm through the ivc wall.¿.
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Search Alerts/Recalls
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