Catalog Number UNKNOWN |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Perforation (2001); Great Vessel Perforation (2152); Blood Loss (2597); No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.
|
|
Event Description
|
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
|
|
Manufacturer Narrative
|
(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(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.
|
|
Event Description
|
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
|
|
Manufacturer Narrative
|
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.(b)(4).
|
|
Event Description
|
Additional information received on 2/15/2017: reason for implant was deep venous thrombosis on the right.Patient alleges the device has tilted and perforated the vena cava, perforated an organ and has experienced bleeding.
|
|
Manufacturer Narrative
|
(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.Patient alleges the device has tilted and perforated the vena cava, perforated an organ and has experienced bleeding.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 received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter tilt is a known potential complication of vena cava filters.Among other causes, filter tilt may be associated with 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 procedure in the vicinity of a filter) and (or) procedures that involve devices passing through a filter, or a failed retrieval attempt.Excessive filter tilt may result in loss of filter efficiency.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature.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.
|
|
Search Alerts/Recalls
|