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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Inadequate Filtration Process (2308); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Anxiety (2328); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
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Event Type
Injury
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Manufacturer Narrative
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It has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog # is unknown but referred to as celect.Occupation: non-healthcare professional.Investigation: the following allegations have been investigated: fracture, organ/vena cava perforation, thrombotic events, inability to retrieve.The reported allegations have been investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.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.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.Catalog number and lot number are unknown, however, the alleged celect 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.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.
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Event Description
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The following information is alleged: the patient received a celect tulip inferior vena cava (ivc) filter on (b)(6) 2008.After the implantation the filter perforated through the patient's ivc, with one strut perforating the patient's duodenum.One strut of patient's filter has fractured and is perforating the patient's right retroperitoneum, just inferior to the kidney.The patient further alleges thrombotic events and an unsuccessful filter retrieval attempt.Hospital and medical records have been requested, but not yet provided.
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Event Description
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Patient allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to deep venous thrombosis with contraindication to anticoagulation secondary to head trauma; followed by an unsuccessful filter retrieval attempt on (b)(6) 2019.A successful, second retrieval attempt is alleged in (b)(6) 2020.Patient is alleging vena cava perforation, fracture, organ perforation, and post implant thrombotic event.Patient further alleges (fragment remains in patient), migration, right retroperitoneum perforation, duodenum perforation, complex removal, anxiety, addiction to pain killers.Retrieval report (unsuccessful): ".Has a fractured strut that has migrated into the right retroperitoneum, just inferior to the kidney.Plan for removal of the inferior vena cava filter, which also has the struts penetrating the cava and one of the struts appearing to involve the duodenum." findings: the inferior vena cava filter is fractured with one of the fracture fragments within the right pelvis.The remainder of the filter struts and balancing components all appear intact.The hook is intact.There is some narrowing within the inferior vena cava filter near the filter apex, likely due to a filter cap/scarring"."unsuccessful inferior vena cava filter retrieval from a right transjugular access using endobronchial forceps.The filter hook and apex are embedded with the wall.".
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.D6b - filter explant: (b)(6) 2020.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.The following allegations have been investigated: embedment, stenosis, complex removal, migration, anxiety, addiction to pain killers.The additional information regarding embedment does not change the previous investigation results for vena cava perforation.The additional information regarding complex removal does not change the previous investigation results for inability to retrieve.The additional information regarding stenosis does not change the previous investigation results for thrombus.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 anxiety addiction to pain killers 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 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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