WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-JUG-CELECT |
Device Problems
Difficult to Remove (1528); Structural Problem (2506); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); Chest Tightness/Pressure (2463); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.It has not been possible to investigate or evaluate this alleged 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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'it is alleged that "[pt] received a cook celect filter on (b)(6) 2014".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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Patient allegedly received an implant on (b)(6)2014 via right internal jugular vein due to pulmonary embolism and deep vein thrombosis.Patient is alleging vena cava perforation and device unable to be retrieved.The patient further alleges ¿i have been having problems breathing and i constantly feel pressure around my chest, neck, and stomach area.I am overwhelmed and depressed because of my condition.¿ per the x-ray abdomen dated (b)(6)2019, ¿redemonstrated is the inferior cava filter with snare hook projecting parallel to the right l2 pedicle.¿.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected fields: b1.The following fields were updated per additional information received: a2, a4, b5, b6, b7, d1, d4, g5, h4, h6.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged perforation.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated.Vena cava (vc) perforation, unable to be retrieved, deep vein thrombosis (dvt), pressure around my chest, neck, and stomach area, breathing problems, overwhelmed and depressed.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and 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.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 pressure around my chest, neck, and stomach area, breathing problems, overwhelmed and depressed are 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 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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b5, b6, and h6.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: organ/aorta perforation.The additional information regarding organ/aorta perforation does not change the previous investigation results for vena cava perforation.20 devices in lot.The product 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.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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Medical opinion: "findings: review of the medical documentation revealed that [patient] underwent the successful infrarenal placement of a cook celect retrievable inferior vena cava filter system on december 23, 2014.Abdominal radiographs, obtained on (b)(6) 2017, were reviewed, and demonstrated an indwelling ivc filter with its apex and hook at the l2-3 level which extended inferiorly to the l4 level.Similarly, a final radiology report from an abdominal radiograph performed on (b)(6) 2019 noted the ivc filter tip and hook to be located at the l2 level.I have also personally reviewed a ct scan of the abdomen and pelvis, performed on (b)(6) 2021, which demonstrated an indwelling ivc filter extending from l2-3 to the l4 level with no evidence of significant ivc filter migration, angulation nor component fracture.However, this ct examination demonstrated at least four (4) significant and pathologic ivc filter component penetrations, extending greater than 3 mm beyond the perceptible exterior wall of the inferior vena cava, as described below: 1.Medial 3 o'clock, 13 mm perforation, grade 4, perforates aorta at level of bifurcation.2.Posterior 6 o'clock, 14 mm, grade 3, abuts anterior aspect of the l4 vertebral body - resultant reactive periosteal new bone formation.3.Lateral 9 o'clock, 13.5 mm, grade 4, perforates right psoas muscle.4.Anterior 12 o'clock, 8.5 mm perforation, grade 2.
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Search Alerts/Recalls
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