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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation of Vessels (2135)
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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 refered to as a celect filter.Occupation: non-healthcare professional.(b)(4).Summary of investigational findings: the reported allegations have been 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.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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Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on or about (b)(6) 2014." it is further alleged that "on or about (b)(6) 2015, the patient's physician attempted to remove the cook celect filter, but was unsuccessful due to the filter having tilted, with the retrieval hook having become adherent to the vein wall.On or about (b)(6) 2018, the patient underwent a ct scan of his abdomen from which it was determined that several of the filter's struts had penetrated the patients ivc vein wall, with one extending as far as 7.7 millimeters outside the vein wall and in close proximity to the patients abdominal aorta" patient outcome: alleged: "for the rest of the patients life, he will require on-going medical monitoring and use of anti-coagulants" and "[pt] has suffered and will continue to suffer serious physical injuries, pain and suffering, mental anguish, medical expenses, economic loss, loss of enjoyment of life, disability, and other losses" hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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Additional information: investigation investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported emotional distress is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot# are unknown, however, the alleged celect is manufactured and inspected according to a43498 (celect mi), a43590 (celect qci).The following allegations have been investigated: emotional distress.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.The following fields were updated per additional information received: a2, a4, b5, b6, b7, h6.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 on (b)(6) 2014 via the right common femoral vein due to bariatric surgery.Patient is alleging vena cava perforation, failed removal.Patient further alleges emotional distress.Retrieval report (attempted): "the ivc filter was tilted and angulated - possibly with the hook tilted into the wall of the right renal vein.10 mm balloon was used to move the filter but the top hook could not be engaged by the snare.The procedure was then terminated." report from computerized tomography (ct): "ivc filter seen in position below the renal veins.The tip appears tilted toward the right.No retroperitoneal hematoma identified." report from computerized tomography (ct): "ivg filter: there is an ivg filter.This lies about 8.9 mm below the right renal vein.The tip of the ivg filter looks like extend slightly outside the wall of the inferior vena cava along the posterolateral aspect of the inferior vena cava on the right.There is a limb of the filter that extends outside the ivg slightly along its anterior margin.There is another limb this extends outside the wall of the filter 7.7 mm and lies anterior to the abdominal aorta.There are additional limbs of the ivg filter which extend slightly outside the wall both laterally and posteriorly." "an ivg filter is noted as described.".
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Search Alerts/Recalls
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