WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
|
Back to Search Results |
|
Catalog Number IGTCFS-65-1-JUG-CELECT-PT |
Device Problems
Difficult to Remove (1528); Material Twisted/Bent (2981); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Ambulation Difficulties (2544); No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
'it is alleged that "[pt] received a cook celect filter on (b)(6) 2018".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
|
|
Manufacturer Narrative
|
Investigation is reopened due to additional information provided.The following allegations have been further investigated based on the information provided to date: tilt, vena cava perforation.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.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 is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
|
Event Description
|
Per the ctabc@ ct abdomen wo cont report dated (b)(6) 2019: "findings: there is an ivc filter located just below the renal veins.The apex of the filter is tilted positioned along the posterior ivc wall.One of the ivc strut loops back within the lumen of the ivc towards the apex of the filter.There is perforation of a right posterior strut with a fat plane of 1.8 mm between the lumen of the ivc and strut.There is perforation of a left posterior strut with a fat plane of 1.8 mm between the lumen of the ivc and strut.There is perforation right anterior strut with a fat plane of 1.8 mm and left anterior strut with a fat plane 1.5 mm".
|
|
Manufacturer Narrative
|
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated.Unable to retrieve, bent strut, anxiety, pain, balance issue, limited mobility and fatigue.The reported allegations have been further investigated based on the information provided to date.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.Unknown if the reported bent strut, anxiety, pain, balance issue, limited mobility and fatigue 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 includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
|
Event Description
|
Patient allegedly received an implant on (b)(6) 2018 via an unspecified vein in conjunction with an orthopedic procedure.An unsuccessful percutaneous filter retrieval was attempted on (b)(6) 2018.Patient is alleging device is unable to be retrieved, tilt, bent strut, and vena cava perforation.Patient notes and further alleges "my left leg all the way to my toes not functioning right have to use a brace now for balance a cane also at time starting to have pains in my lower back neck still hurts from the inserting of the filter can't really do activities used to can't walk a long time or stand long without getting really tired".The patient further notes "my anxiety actually started i believe when the first attempt to get this ivc out and it failed 2018 recently started medication in (b)(6) 2019".
|
|
Search Alerts/Recalls
|
|
|