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| Catalog Number UNKNOWN |
| Device Problems
Migration or Expulsion of Device (1395); Difficult to Remove (1528); Structural Problem (2506); Insufficient Information (3190)
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| Patient Problems
Pulmonary Embolism (1498); Emotional Changes (1831); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); Blood Loss (2597); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It is alleged that the plaintiff received a gunther filter on (b)(6) 2007.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.
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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 provided to date via the operative note stating, ¿gunther tulip filter implanted." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.
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Manufacturer Narrative
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(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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This additional information received on 02feb2018 as follows: pt allegedly received an implant on (b)(6) 2007 via the right common femoral vein to prevent blood clots.Pt alleges bleeding.Pt further alleges post implant deep vein thrombosis, post implant pulmonary embolism,pain,anxiety,depression.Attempted retrievals performed on (b)(6) 2015, (b)(6) 2015, (b)(6) 2015 and (b)(6) 2016.
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Manufacturer Narrative
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Investigation is reopened due to additional information provided.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'gunther-bleeding, post implant dvt, pe, pain, anxiety, depression.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.Unknown if the reported anxiety, depression, and bleeding is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this time.Rpn and lot# are unknown, but the tulip filter is manufactured and inspected according to a41935 (tulip mi) and a41936 (tulip qci).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 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.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation is reopened due to additional information provided.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'gunther-bleeding, post implant dvt, pe, pain, anxiety, depression.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.Unknown if the reported anxiety, depression, and bleeding is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this time.Rpn and lot# are unknown, but the tulip filter is manufactured and inspected according to a41935 (tulip mi) and a41936 (tulip qci).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 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 received the filter due to hypercoagulable state: multiple episodes of lower extremity deep vein thrombosis (dvt) despite anticoagulation.Patient additionally alleges vena cava and organ perforation and the device is unable to be retrieved.Patient notes and further alleges experiencing "worry" and post traumatic stress disorder (ptsd).Per a 10jul2019 ct: "caval perforation: yes.Grade 3 perforation of 2 o'clock strut into duodenum.Grade 2 perforation of 4 o'clock strut 0.44 cm.Grade 1 perforations of the other legs.Tilt: yes.3.08 degrees of sagittal tilt.Apex of filter touches posterior wall of ivc.Migration: yes.Apex of filter 0.5 cm above the left renal vein confluence.Pertinent negatives: no fracture or missing struts identified.No ivc stenosis".
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava/org perforation, unable to retrieve, migration, tilt, post traumatic stress disorder, worry, pain.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.The current verbiage has been added to further investigate the previously alleged deep vein thrombosis (dvt).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.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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.Unknown if the reported ptsd, worry, and pain 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, but the tulip 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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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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