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Catalog Number UNKNOWN |
Device Problems
Structural Problem (2506); Device Tipped Over (2589); Insufficient Information (3190)
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Patient Problems
Pain (1994); Perforation of Vessels (2135); Depression (2361); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.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 celect filter on (b)(6) 2009.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".
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Manufacturer Narrative
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Investigation: the following allegations have been investigated: vena cava perforation, tilt, pain, emotional turmoil, limited mobility, swelling, back pain/tingling, extremity numbness, depression.Investigation is reopened due to additional information provided.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.Unknown if the reported pain, emotional turmoil, limited mobility, swelling, back pain/tingling, extremity numbness, depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged celect is manufactured and inspected according to controls.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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Patient allegedly received an implant on (b)(6) 2009 via the right common femoral vein due to pulmonary embolism.The patient alleges tilt and vena cava perforation.The patient further alleges pain, emotional turmoil, limited mobility, swelling, chronic lower back pain, numbness in limbs and extremities, tingling in lower back and limbs, depression.(b)(6) 2019, per a report from computed tomography; ¿on the coronal imaging, it is mildly tilted to the right.Quote 2: there are multiple limb perforations numbering at least four and suggestion of two additional anterior partial perforations.¿.
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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.Catalog number and lot number are unknown; however, the alleged filter is manufactured and inspected according to controls.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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29jun2021, per a report from medical opinion; ¿ivc filter is infrarenal in position.The anterior- lateral filter strut is seen piercing the corresponding wall of ivc (13.64mm) is seen impinging the duodenal wall anteriorly.The posterior lateral strut is seen piercing the corresponding wall of ivc (10.67mm) and is seen impinging the right psoas muscle.The anterior medial strut is seen piercing the corresponding wall of ivc (9.59mm).There is no obvious tilt of the ivc filter.No ivc filter fracture is noted.¿.
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Search Alerts/Recalls
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