COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number G33016 |
Device Problems
Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135)
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Event Type
Injury
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Manufacturer Narrative
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The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2020-00202.Occupation: non-healthcare professional.(b)(4).Additional information: investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava/renal vein perforation ,embedment ,inability to retrieve, tilt, uneasy feeling.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 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.Unknown if the reported uneasy feeling 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.
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Event Description
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Patient allegedly received an implant on (b)(6) 2013 via the right common femoral vein due to deep vein thrombosis.Patient is alleging tilt, vena cava perforation and embedment.Patient is further alleging uneasy feeling.Per a (b)(6) 2013 unsuccessful filter retrieval report: "the filter apex was tilted to the right, and indenting the wall of the cava." "the filter retrieval sheath was then placed into the ivc over a 0.035 inch amplatz wire.The gooseneck snare was deployed, and multiple attempts made to snare the filter unsuccessfully.Next, a c2 catheter and a deflecting-tip wire were advanced through the sheath, and again multiple attempts were made to displace the tip of the ivc filter without success.[physician] spoke with [physician] directly, and it was decided to maintain the filter in its current position." "despite numerous attempts, unsuccessful percutaneous ivc filter removal." report from computerized tomography (ct): "there is an inferior vena caval umbrella extending from the level of the l2 vertebral body down to the level of the l4 vertebral body.The apex of the umbrella is at the level of the right renal vein entrance and the apex protrudes into the right renal vein.The umbrella long-axis is tilted to the right superiorly.The inferior strut protrude through the ivc wall but do not penetrate any additional surrounding structures.".
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.A total of 20 devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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 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.
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Event Description
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Per computed tomography report, "filter position: below above the renal veins." "filter tilt: yes." "filter penetration: yes." "the filter is tilted posterior with its proximal cone 10 mm through the ivc wall." "the anterior right strut penetrates 4 mm through the ivc wall." "the anterior left strut penetrates 10 mm through the ivc wall." "the posterior right strut penetrates 8 mm through the ivc wall." "the posterior left strut penetrates 0 mm through the ivc wall." per medical opinion, "the patient¿s ivc filter is a cook gunther-tulip retrievable ivc filter positioned in the patient¿s infrarenal ivc at the l1-2 level.The ivc measures 20 mm in maximum diameter at the level of the filter.The filter is tilted 13 degrees medially and 8 degrees posteriorly, such that the filter apex and hook are in very close proximity to the posterior caval wall just below renal veins.All four (4) of the filter¿s legs (primary struts) perforate the wall of the ivc by a distance of 3 mm or greater.The perforating anterior struts impinge directly on the posterior wall of overlying small bowel.".
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