WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-FEM-CELECT-PT |
Device Problems
Structural Problem (2506); Appropriate Term/Code Not Available (3191)
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Patient Problems
Perforation of Vessels (2135); Anxiety (2328); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect 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.
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Event Description
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It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2015, and the patient 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) 2015 via the right common femoral vein due to gastric bypass.Per radiology report, "the anterior lateral filter strut is seen piercing the anterior lateral wall of ivc (9.4mm) and lying anteriorly." "the anterior medial filter strut is seen piercing the anterior lateral wall of ivc (8.5mm) and lying anteriorly, impinging bowel." "the posterior lateral filter strut is seen piercing the corresponding wall of ivc (7mm)." anxiety.
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, anxiety.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.Unknown if the reported anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog is known, the lot number is unknown, however, the alleged celect-pt 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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Manufacturer Narrative
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G4 (510k): k171712.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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It is alleged that the patient received a celect pt inferior vena cava (ivc) filter on (b)(6) 2015.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, b6.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.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 the 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 medical opinion, ""the anterior lateral filter strut is seen piercing the anterior lateral wall of ivc (9.4mm) and lying anteriorly." "the anterior medial filter strut is seen piercing the anterior lateral wall of ivc (8.5mm) and lying anteriorly, impinging bowel." "the posterior lateral filter strut is seen piercing the corresponding wall of ivc (7mm)." "there is no tilt of the ivc filter.No ivc filter fracture noted".
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Search Alerts/Recalls
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