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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-1-FEM-CELECT-PT |
| Device Problems
Difficult to Remove (1528); Device Tipped Over (2589); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Pain (1994); Bowel Perforation (2668)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog # is unknown but referred to as cook ivc filter.Occupation: non-healthcare professional.(b)(4).Summary of investigational findings: it has not been possible to investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿unable to retrieve, embedded, vc & organ perforation, fracture".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.A filter that is embedded in the wall of the ivc may be difficult to retrieve.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), excessive force or manipulations near an implanted filter (e.G.A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that filter fragment embolized into the heart or lung may be safely retrieved.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 medical will continue to monitor for similar events.
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Event Description
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Description of event according to categorization form: [pt] alleges: "(b)(6) 2017 failed retrieval attempt", "(b)(6) 2017 exam shows filter coiled upon itself with one leg possibly embedded into the duodenum".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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Event Description
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Per a report from ct (computed tomography) dated (b)(6) 2017, "inferior vena cava coiled upon itself with one limb possibly embedded into the duodenum.".
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Manufacturer Narrative
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The investigation was 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.As a result, appropriate term/code not available (4316) was selected for the conclusion code.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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Manufacturer Narrative
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The following fields were updated per additional information received.Additional information: investigation: the investigation was reopened due to additional information provided.The following allegation has been investigated: tilt.The reported allegations have been further investigated based on the information provided to date.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 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 successful retrieval report, "fluoroscopic imaging demonstrated the tilted ivc filter fragments and filter neck." "inferior venacavogram was performed from the right ij sheath, which demonstrated a normal caliber patent ivc without evidence of intraluminal thrombus.Multiple filter struts as well as the filter neck were seen protruding outside the ivc lumen.Alligator forceps were used from both access sheaths to grasp filter struts from above and below; several filter struts were removed during this process.After multiple attempts, both the ivc filter struts and neck were successfully dislodged and ultimately retrieved into the right ij vascular sheath, which was subsequently removed.Completion inferior venacavogram demonstrated no extravasation of contrast and no residual filter struts." "successful forceps-assisted removal of ivc filter with no residual struts".
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a4, b5, b6, b7, d1, d4, g5, h4, h6.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: migration, scars, pain.The reported allegations have been further investigated based on the information provided to date.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.Unknown if the reported scars and pain are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No other complaints on lots.Product 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.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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Patient allegedly received an implant via right common femoral vein due to deep vein thrombosis (dvt).Patient is alleging migration; vena cava perforation and device is unable to be retrieved.The patient further alleges pain and three (3) scars on neck.Per an attempted ivc filter retrieval operative report dated 24jul2017, ¿cavogram was performed.The cava was widely patent.The filter was in good position.Despite numerous different snare techniques and different types of the catheters, the ivc filter could be snared but not withdrawn into the extraction catheter.¿ per an attempted ivc filter retrieval operative report dated 31aug2017, ¿ivc venography: filter integrity: fractured.Hook position: embedded in the wall.The filter was captured, collapsed into the sheath and removed in its entirety.Post retrieval venography: ivc filter still present in the infrarenal ivc.Impression: unsuccessful inferior vena cava filter retrieval.¿ patient notes an attempted ivc filter retrieval on 09oct2017 without further details.
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Manufacturer Narrative
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Manufacturer ref (b)(4).Summary of investigational findings: 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.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 the 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.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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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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