COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
|
Back to Search Results |
|
Catalog Number IGTCFS-65-FEM |
Device Problems
Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Abdominal Pain (1685); Perforation of Vessels (2135); Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
Reporter 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 tulip 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.
|
|
Event Description
|
It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2009, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
|
|
Manufacturer Narrative
|
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, tilt, stress, abdominal pain.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: 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 stress and abdominal pain are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 10 devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specification.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.
|
|
Event Description
|
Patient allegedly received an implant on (b)(6) 2009 via the right common femoral vein due to pulmonary embolism (pe).Patient is alleging vena cava perforation, and tilt.Patient further alleges "stress and abdominal pain." per computed tomography report, "open cell ivc filter is in place, superior extent approximately 1 cm inferior to the insertion of the right renal vein.It is tilted superiorly medially.4 struts penetrate ivc wall, medial strut is intimately associated with the right lateral aortic wall.No pericaval infiltration or vertebral cortical penetration is seen".
|
|
Manufacturer Narrative
|
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.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.A total of 10 devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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.
|
|
Event Description
|
Per computed tomography, "filter position: below the level of the renal veins." "the filter is tilted to the left with its proximal cone against the ivc wall." "the anterior strut penetrates 7 mm through the ivc wall." "the left strut penetrates 6 mm through the ivc wall." "the posterior strut penetrates 7 mm through the ivc wall." "the right strut penetrates 8 mm through the ivc wall.".
|
|
Search Alerts/Recalls
|
|
|