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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-1-FEM-TULIP |
| Device Problems
Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Dyspnea (1816); Internal Organ Perforation (1987); 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).Catalog #: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057.Mfr date unknown as lot # is unknown.Investigation is still in progress.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2014." patient outcome: it is alleged that [pt] 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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(b)(4).Catalog#: unknown but referred to as a cook günther tulip filter.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.(b)(4).Information regarding the event has not been provided.It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received.If additional information is received, the report will be re-opened for further investigation.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2014".Patient outcome: it is alleged that [pt] 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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(b)(4).According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2014." patient outcome: it is alleged that [pt] 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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Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of(b)(4).(b)(4).(b)(6).The event is currently under investigation.A supplemental report will be provided upon conclusion.
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Event Description
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This additional information was received on 11/17/2016 as follows: the plaintiff allegedly received device implant via right femoral vein on (b)(6) 2014 due to dvt and high risk for pe.The plaintiff alleges bleeding, shortness of breath, chest pain, and emotional distress in after implant of device.
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Manufacturer Narrative
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Manufacturer reference #: (b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction.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 ¿bleeding, shortness of breath, chest pain, emotional distress".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Unknown if the reported 'bleeding, shortness of breath, chest pain, emotional distress' 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.
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Event Description
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The patient further alleges tilt, vena cava perforation, organ perforation, device is unable to be retrieved, the hook is embedded in the ivc wall, one medial strut perforates the ivc wall 10mm and contacts the aorta and one posterior strut perforates the ivc wall 16mm and contacts the l3-4 disc.Patient also alleges swelling in legs.Per a ct (computed tomography) scan of the abdomen and pelvis dated (b)(6)2019, ¿infrarenal ivc filter perforating through the ivc with multiple struts extending extraluminal.The above mentioned ivc filter is considered temporary and removable.However, secondary to the position as described, it does not appear amenable to percutaneous endovascular removal.¿.
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Manufacturer Narrative
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Patient code(s): vessels, perforation of (2135), organ(s), perforation of (1987) and vessel or plaque, device embedded in (1204) were added in addition to the previously submitted patient codes.Device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.Device code(s): appropriate term/code not available (3191) was selected for the alleged perforation.Investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, organ perforation, unable to retrieve, embedded, tilt, swelling in legs 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 swelling in legs 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.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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