WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-JUG-TULIP |
Device Problems
Structural Problem (2506); Device Tipped Over (2589); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
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Patient Problems
Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135); Bowel Perforation (2668)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Initial mdr was submitted by cook inc under manufacturer report reference# 1820334-2019-02691.Additional information provided determined that this device was manufactured by william cook europe.With the submission of this initial report, william cook europe informs that all future submissions regarding this complaint will be handled under manufacturer report reference# for this complaint.Non-healthcare professional.510(k): k172557.Appropriate term/code not available for perforation summary of investigational findings: 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.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 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 the patient received a gunther tulip on (b)(6) 2009.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.Additional information received on 02dec2019: patient allegedly received an implant on (b)(6) 2009 via the right internal jugular vein post deep vein thrombosis (dvt).Patient is alleging tilt, vena cava perforation, and organ perforation.Relevant tests: (b)(6) 2009, implant report: "an ivc gram was performed at that time demonstrating a normal ivc without evidence of venous anomaly or intraluminal thrombus." "successful ivc gram and infrarenal gunther tulip removable filter placement.The right internal jugular vein approach was utilized." (b)(6) 2009, report from ct (computed tomography): "ivc filter." (b)(6) 2019, report from ct: "vena cava filter appears to reside in the inferior vena cava.The larger struts are projecting along the wall or just beyond the wall.The 2 most posterior struts may project 1 to 2 mm beyond the wall.The anterior struts intimately associated with the wall.The smaller stress are also fell to be intimately associated with the wall though the medial bowel struts cannot be excluded from minimal perforation.The filter is oriented with the tip lo the left side of the vena cava.Scoliosis limits evaluation of the tilt angle.Scoliosis convex right.This may be 5 degrees off the vertical tilted toward the left.The anterior struts are intimately associated as described with the wall and this is also intimately associated with the crossing duodenum anteriorly.The tip of the vena cava filter is at the level of approximately superior aspect of l1.This appears to be just above the entrance of the renal veins.The calcification described in the lower right liver is linear and therefore would be difficult to completely exclude a migrated piece of struts into the liver." patient outcome: unknown.
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Manufacturer Narrative
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Additional information: 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.803.56.20 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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Report from ct (computed tomography): "filter type: cook gunther tulip.Ivc stenosis: no.Filter position: below the level of the renal veins.Impressions: the anterior strut penetrates 4 mm through the ivc wall.Sagittal image 45.The left strut penetrates 10 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes.Coronal image 32.The posterior strut penetrates 4 mm through the ivc wall.Sagittal image 46.The right strut penetrates 3 mm through the ivc wall.Coronal image 30.".
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Search Alerts/Recalls
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