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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-1-UNI-TULIP |
| Device Problems
Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589); Activation Failure (3270)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Great Vessel Perforation (2152)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer ref# (b)(4) catalog# is unknown but referred to as cook gunther tulip filter.Reporter occupation: non-healthcare professional.Pma/510(k) k172557.Summary of investigational findings: 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.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.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 collapsed filter is directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.Cook medical will continue to monitor for similar events.
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Event Description
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It is alleged that "[pt] received a gunther tulip filter on or about (b)(6) 2014.On or about (b)(6) 2014, removal of the cook gunther tulip filter was attempted, but failed due to the fact that the filter was tilted, collapsed, and had perforated the vena cava.This filter was left in [pt]'s body, and a second filter was placed.This filter was a cookcelect.Hospital and medical records have been requested but not yet provided." it is alleged that "[pt] suffered permanent and continous injuries, including physical pain and suffering, mental anguish, physical impairment, loss of enjoyment of life, physical disfigurement".
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Manufacturer Narrative
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G4 (510k): k172557.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: vena cava (vc) perforation, unsuccessful removal, filter collapsed, tilt, failure to open, 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.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 collapsed filter, failure to open, and fear are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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 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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Patient allegedly received a gunther tulip inferior vena cava filter on (b)(6) 2014 via the left femoral vein due to cervical spine injury/quadriplegia and high risk for deep vein thrombosis and pulmonary embolism, per medical records.This was followed by an unsuccessful retrieval attempt on (b)(6) 2014 due to the tulip was malpositioned/did not operate correctly and subsequent placement of a cook celect filter.Patient is alleging the gunther tulip filter tilted, perforated the inferior vena cava and was unable to be retrieved.The patient notes and further alleges experiencing "fear that the [tulip] filter might cause further damage as it has not yet been removed".Per the gunther tulip inferior vena cava filter placement: "the dilator was then removed and the filter was inserted into vena cava using the delivery mechanism under fluoro.After ascertaining proper positioning, the filter was delivered at the level of l2.The position was satisfactory but the filter did not open fully"."the plan is to retrieve the misfired filter and place another one in the near future asap".Per report from x-ray: "in the area is an ivc filter obliquely oriented just to the right of l1-2, similar in alignment 2 spot images obtained day previously intraoperatively." per the unsuccessful gunther tulip filter retrieval: "malpositioning of inferior vena cava with incomplete deployment secondary to partial perforation and retroperitoneal positioning of the vena cava filter"."as we continued to advance further, it was apparent that the filter was outside of the wall of the vena cava and the main portion of the filter was positioned alongside the vena cava and completely collapsed.At this point, there were no further attempts to retrieve the filter.I did look at the surrounding images around the filter and there was no apparent hematoma in that area and therefore the filter was left undisturbed as we selected a site just below the main body of l2 to put a second filter".Per the computed tomography (ct) abdomen and pelvis with contrast: "there are 2 infrarenal ivc filters present one of which does not appear fully deployed".
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