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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026)
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| Patient Problems
Pulmonary Embolism (1498); Internal Organ Perforation (1987); Thrombus (2101); Perforation of Vessels (2135); Anxiety (2328); Atrial Perforation (2511)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Reporter occupation: non-healthcare professional.(b)(4).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 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.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to initial reporter: "on or about (b)(6) 2012, [pt] was implanted with a cook celect vena cava filter".On or about (b)(6) 2016, [pt] underwent an attempted removal of his ivc filter at (b)(6) medical center.During the procedure, several images were taken of [pt]¿s ivc which revealed the cook ivc filter had moved since its implantation with several legs now protruding outside of [pt]¿s ivc.The cook filter was also noted to be severely tilted with the hook and tip of the filter in close approximation to [pt]¿s ivc wall.Despite several attempts at removing the filter during this percutaneous procedure, [pt]¿s temporary cook celect ivc filter ultimately could not be removed.In (b)(6) 2016, [pt] underwent a computed tomography (¿ct¿) scan in preparation for another potential ivc filter removal surgery.This ct scan revealed several of the cook ivc filter legs now were eroding into [pt]¿s spine.Further, another cook ivc filter leg now extended into [pt]¿s abdominal aorta.Several days after this ct scan, on or about (b)(6) 2016, [pt] underwent a second attempted removal of his cook ivc filter at (b)(6) medical center.Because [pt]¿s cook filter had become so embedded in his ivc wall, a balloon angioplasty, along with various snares and catheters, were used to attempt to dislodge the cook filter from his ivc wall.Despite these methods, the cook ivc filter could not be removed.Patient outcome: it is alleged that "[pt] is now at risk for future cook filter fractures, migrations, perforations, and tilting.[pt] faces numerous health risks, including the risk of death.For the rest of his life, [pt] will require ongoing medical care and monitoring.[pt] has also suffered significant, disfiguring injuries, including significant pain and distress restricting his ability to engage in activities of daily living.Furthermore, [pt] has incurred substantial medical expenses as a result of cook¿s defective device, and, on information and belief, he will continue to incur substantial medical expenses in the future.".
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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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Manufacturer Narrative
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Manufacturers ref# (b)(4).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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Retrieval report (attempted): "the filter appears slightly tilted and orientation as compared to prior examination." "venography was performed which demonstrated appropriate position of the filter without evidence of clot.The filter does appear tilted with the retrieval hook in close proximity to the right wall of the cava.There appears to be penetration of the medial wall of the ivc by at least three of the legs of the filter.There is no evidence of luminal irregularity of the vessel.Extensive attempts were made to engage the hook of the filter using en-snare and goose neck snare devices of multiple sizes.The neck of the filter could not be freed from the vessel wall." "infrarenal ivc filter in place intact without evidence of fracture or captured thrombus.The filter is tilted to the right lateral aspect with the hook of the filter incorporated into the vessel wall.There appears to be caval penetration of the medial aspect of the ivc by at least three legs of the filter." report from ct (computed tomography): "there is an ivc filter which is tilted with the apex along the right anterolateral wall of the inferior vena cava.Multiple tines have penetrated through the wall of the inferior vena cava.Some of the tines have eroded into the l4 vertebral body.Another leg has penetrated through the ivc wall into the aorta." retrieval report (attempted): "a venogram was performed at the level of the indwelling filter and shows patent vessel without clot.The filter is intact with medial penetration of a filter leg as seen on prior ct examination.Multiple attempts were made to initially engage the retrieval hook of the filter were unsuccessful as the hook appears incorporated within the lumen of the ivc." "impression: unsuccessful attempt at retrieval of infrarenal ivc filter secondary to incorporation of the retrieval into the vessel lumen.Intact infrarenal ivc filter.".
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Manufacturer Narrative
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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.Catalog number and lot number are 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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become 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 the right jugular vein due to trauma.Patient is alleging tilt, vena cava perforation, organ perforation, failed removals, and filter embedment.The patient further alleges "must be on blood thinners for the remainder of my life due to failed ivc filter [removal].Constantly developing blood clots and dvt, blood clots have passed the filter and reached lung, fear, depression, and anxiety that it is eventually going to be fatal, pain associated with numerous clots/dvt's and hospitalizations and my quality of life resulting from it" and "unable to [lift] heavy objects or do strenuous activity.Have to have leg propped up to heart level to try and reduce clots from forming and pain levels." report from xray: "an ivc filter is noted in place.This is positioned at approximately the l3 vertebral level to the right of midline." report from venogram: "there is thrombus extending from the popliteal vein into the iliac system.There appears to be some stenosis of the common iliac vein.The ivc is patent with filter in place.There is thrombus within the filter and ivc.Thrombolysis was performed using a mechanical truss device.At the end of the procedure.There is clearing of the thrombus from the superficial femoral artery.There is some residual thrombus in the iliac veins." report from ct: "ivc filter with prongs that extend outside ivc, one entering the aorta.".
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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, 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: pulmonary embolism, dvt/thrombus/stenosis, permanent anticoagulation, fear, depression, anxiety, pain, physical limitations.New pe 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: pulmonary embolism.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.Unknown if the reported permanent anticoagulation, fear, depression, anxiety, pain, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are 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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become 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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Search Alerts/Recalls
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