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| Catalog Number UNKNOWN |
| Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Additional information: 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; 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.
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Event Description
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It is alleged that the patient received a gunther tulip on (b)(6) 2007.It is alleged that the patient 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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Corrected information: h6 (device code) device dislodged or dislocated (2923) which was not included in the previous regulatory report.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: occluded inferior vena cava, displaced filter.The reported allegations have been further investigated based on the information provided to date.The new information regarding ivc occlusion does not change the previous investigation results.Unknown if the reported displaced filter is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown, however, the device is manufactured and inspected according to current 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 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 a (b)(6) 2018 venacavagram, inferior: "diagnostic venography demonstrates and [sic] infrarenal ivc [inferior vena cava] filter with complete obliteration of the infrarenal ivc and bilateral common iliac veins.Status post unsuccessful attempt at ivc filter removal, ivc filter was displaced and affixed by ivc stent; venoplasty and ivc and bilateral common iliac stent placement".Addendum to the (b)(6) 2018 venacavagram dated (b)(6) 2018: "the ivc was completely occluded and required revascularization.The bilateral iliac veins were also occluded with collaterals and required separate access, lesion crossing and stenting.The occlusion was continuous from the ivc caudal to the filter to the bilateral iliac veins".
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Manufacturer Narrative
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Additional information: (patient and device codes).H6 (device code): appropriate term/code not available for vessel perforation.H6 (device code): appropriate term/code not available for organ perforation.H6 (device code): appropriate term/code not available for device tilt.Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated.Vena cava (vc)/organ perforation, tilt, unable to retrieve, deep vein thrombosis (dvt), pain, le (lower extremity) edema, stasis ulcer requiring wound care, venous system repair-unconsciousness and post traumatic stress disorder (ptsd).Vena cava wall penetration/perforation has been reported and 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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).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.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported pain, lower extremity edema, stasis ulcer requiring wound care, venous system repair-unconsciousness and ptsd are directly related to the filter and unable to identify a corresponding failure mode at this point in 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 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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Event Description
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Patient allegedly received an implant via the right common femoral vein due to post deep vein thrombosis (dvt).Patient is alleging device tilt and unable to retrieve, vena cava and organ perforation, massive dvt in left lower extremity.Patient notes and further alleges experiencing "massive dvt with painful edema left lower extremity; numerous ineffective capillary workarounds; massive unresolved stasis ulceration left ankle region; unrelenting pain and suffering from device failure, ulcers; edurance [sic] of wound care procedures; 2018 post retrieval attempt and venous system repair-suffered unexplained unconsciousness; stroke team intervention and hospitalization for same day surgery procedure.Persistent wound care issues; persistent left lower leg pain, persistent left lower leg pain, persistent swelling of left lower leg 2019 post repair.Persistent pain swelling of left lower leg; wound care every 2 days; visits to va".Additionally, patient alleges post traumatic stress disorder (ptsd) and an unsuccessful filter retrieval attempt in 2018.Per the inferior vena cava (ivc) filter placement report dated (b)(6) 2007: "successful placement of a guenther [sic] tulip retrieval ivc filter within the infrarenal cava".Per the (b)(6) 2018 ct abdomen pelvis: "infrarenal ivc filter in place.4 inferior prongs extend beyond the margin of the ivc.The posterior prong is 0.5 cm from the margin of the ivc, the right lateral pons 0.6 cm, the left medial prominent 0.4 cm, and the anterior problem approximately 0.3 cm.Ivc caliber inferior to the filter is very small, decreased compared to prior study.Impression: infrarenal ivc filter in place with the inferior prongs extending beyond the lumen of the ivc, as described above.Narrowed ivc caliber, likely reflecting chronic change/thrombosis".
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Search Alerts/Recalls
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