WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-FEM-TULIP |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Scar Tissue (2060); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog # is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.(b)(4).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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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2013".Patient outcome: 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) 2013 via the right common femoral vein as prophylaxis, due to factor 8 blood clotting disorder, prior to gastric sleeve surgery.Patient alleges tilt, ivc removal, psychological distress and ivc was almost irretrievable as it had shifted and was embedded in the aorta.Patient further alleges to have experienced, damage and scar tissue.Filter explanted on (b)(6) 2017.
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Manufacturer Narrative
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Corrected data: b1, h1 additional information a2, b5, b6, b7, d1, d4, h4, g5.F10: patient code: vessel or plaque, device embedded in (1204), listed on ifu scar tissue (2060), not listed in ifu device code: appropriate term/code not available (3191) [device tilt], not listed in ifu.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.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.
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Event Description
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No additional information provided at this time.
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Manufacturer Narrative
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Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.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.Unknown if the reported psychological distress and scar tissue are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on wo for neither device ((b)(4)) lot: e3037398, nor filter (igtf-30) lot:(e3033397 + e3033022).One other complaint ((b)(4)) on lot.The following allegations have been investigated: tilt, psychological distress, embedded, scar tissue.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.
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Search Alerts/Recalls
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