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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Disability (2371); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Occupation: non-healthcare professional.The event is currently under investigation.A supplemental report will be provided upon conclusion.
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Event Description
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It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter device on (b)(6) 2009.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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Additional information received identified the patient allegedly received an implant on (b)(6) 2009 via the right common femoral vein due to pulmonary embolism.The patient is alleging vena cava perforation (computed tomography scan).The patient further alleges, "i live with the anxiety of having a filter that could fail at any time, but that may not be retrievable without serious surgery.I live with the fear that my filter has tilted within my vena cava and perforated outside of it".Additionally, the patient alleges limited ability or inability regarding running, hiking and lifting.
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Manufacturer Narrative
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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: vena cava perforation, anxiety, fear, disability.Vena cava wall penetration/perforation has been reported and 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 anxiety, fear, and disabliity are directly related to the filter and unable to identify a corresponding failure mode at this time.Catalog # and lot # is unknown, however, the device is manufactured and inspected according to current 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.
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Event Description
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Per the independent review of a (b)(6) 2017 ct (computed tomography) scan of abdomen and pelvis dated (b)(6) 2017: "positive for caval perforation.Superior extent of ivc [inferior vena cava] filter mid l2 vertebral body.Inferior extent mid l3 vertebral body.A total of four prongs have perforated the ivc"."maximum distance prongs perforated 4 mm"."coronal images 2 degree tilt left to right"."sagittal images 8 degree tilt posterior anterior series"."diameter of ivc directly above filter 28 mm x 30 mm ".
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: b1, b2, h1 additional information: b5, b6, h6 (device code) h6 (device code): appropriate term/code not available for device tilt investigation: investigation is reopened due to additional information provided.The following allegations have 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.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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Manufacturer Narrative
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H6 conclusion code(s): appropriate term/code not available (4316) was selected because the previous investigation remains unchanged by the additional information.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.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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Event Description
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Per the 21jul2017 ct abdomen and pelvis with contrast: "impressions: 1.An ivc filter is noted with satisfactory orientation and no evidence of significant tilting.2.The filter does demonstrate some projection of centimeters limits extrinsic to the intraluminal wall of the cava, for the approximately 9 mm on its lateral aspect and 7.0 mm medially.3.The filter cephalic tip is located at the mid level of the region of the left renal vein takeoff.4.No wall irregularity of the ivc, definitive thrombus, or alteration and contour is suggested.No extraluminal fluid collections are noted".
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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: b5, d6b, h6 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: complex removal, depression.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 depression is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown, however, 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 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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Event Description
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Additional information has been received and patient is alleging a percutaneous, complex filter retrieval procedure on (b)(6) 2021.Patient notes and further alleges experiencing depression.
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Search Alerts/Recalls
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