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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Model Number G52916 |
| Device Problems
Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Difficult to Remove (1528); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Thrombosis (2100); Perforation of Vessels (2135)
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| Event Date 08/14/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.
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Event Description
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Description of event according to study: during the index procedure on (b)(6) 2017, the patient received a günther tulip filter.The primary reason for filter placement was a current deep vein thrombosis with a contraindication to anticoagulation related to a recent stroke/neurological event, recent major bleeding and lupus.The inferior vena cava (ivc) diameter at the intended filter location was 22 mm.There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.Using the right internal jugular vein as the access site, a günther tulip filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe).The filter neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, migration, or extravasation of contrast after placement.Filter legs did not appear outside the column of contrast after filter placement.Filter tilt was 6 - < 11 degrees.On the same day, the post-placement x-ray was performed.There was no evidence of filter fracture, embolization, or migration.Filter tilt was 6 - < 11 degrees.On (b)(6) 2017, an ultrasound revealed a new caval thrombosis and new dvts in the right pelvic veins and right lower extremity.No treatment was required.The investigator determined that the right pelvic and lower extremity dvts were possibly related to the study device and the patient¿s pre-existing venous thromboembolic disease caused or contributed to the event.The device did not malfunction or deteriorate in characteristics or performance.Patient outcome: the patient remains in the study.
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on event description and image review.The tulip filter was deployed in an infrarenal location via a jugular approach without evidence of significant tilt or immediate perforation.At the time of deployment, there was extensive left iliac venous thrombosis extending to the junction of the right and left common iliac veins, but not into the inferior vena cava.The entire visualized component of the left iliac system was thrombosed.Follow-up almost two months later demonstrates interval development of right iliac and common femoral vein thrombosis, likely interval development of caval thrombosis and confirmation of extensive left lower extremity thrombosis involving the iliac veins to below the level of the popliteal veins.The caval thrombosis and right iliac and common femoral venous thrombosis were new when compared to venogram and ultrasound from filter placement.Given the extensive thrombus present in the left iliac system at time of ivc filter placement, this interval development of caval and right-sided thrombus is likely related to the pre-existing thrombus burden and potential propagation or extension of the thrombus to the level of the ivc filter.There is no discussion in the complaint report regarding any anticoagulation therapy with the filter in place.The other possibility is a portion of the pre-existing thrombus became dislodged and entrapped in the ivc filter, acting as a nidus for propagation.The least likely scenario is that the ivc filter acted as a nidus for intrinsic clot formation which then propagated distally.Although it is well reported in the literature that the presence of an ivc filter, even in the setting of anticoagulation, does increase the risk of caval and lower extremity thrombosis.In this setting, with a large amount of pre-existing left iliac venous thrombosis, this pre-existing thrombus is felt to be more likely the cause of developing caval and right lower extremity venous thrombosis.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.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 medical will continue to monitor for similar events.
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Event Description
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Additional information received 22feb2018.The investigator determined that the caval thrombosis identified on (b)(6) 2017 was possibly related to the study device and the filter placement procedure.
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.
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Event Description
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Additional information received on 28feb2018: on (b)(6) 2018 (250 days post-procedure), the pre-retrieval x-ray was performed.There was no evidence of filter fracture or embolization.There was evidence of filter migration and tilt was = 16 degrees.On the same day, it was determined that the filter was no longer clinically needed.Filter legs did appear outside the column of contrast before retrieval.There was no thrombus present in the filter.The right internal jugular vein was used for filter retrieval.A cook 16 french sheath and tissue forceps were used to retrieve the filter.The physician reported major difficulty attempting to retrieve the filter.The filter was successfully endovascularly retrieved and there was no extravasation of contrast after retrieval.
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Manufacturer Narrative
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Patient code: 2135 - perforation of vessels.Device code:3191 ¿ no code available, for perforation of vessel.Summary of investigational findings: complaint was reopened due to additional information received on 28feb2018.On date of retrieval 250 days post-procedure there was evidence of filter migration and tilt was = 16 degrees.Filter legs did appear outside the column of contrast before retrieval.The physician reported major difficulty attempting to retrieve the filter.Investigation is based on event description and image review.The image review did not confirm the reported filter tilt and filter migration.However, the left lateral most primary filter leg was seen extending outside of the column of contrast by approximately 13mm, indicating penetration.The right lateral most primary filter foot also extends out of the column of contrast by approximately 4mm.The anterior most primary filter leg also extends 7mm outside of the column of contrast.These penetrations likely contributed to the difficulty in retrieving the filter, which was successful utilizing advanced techniques.Follow-up venogram demonstrated mild irregularity involving the left lateral wall of the ivc, without evidence of active extravasation.The irregularity was likely due to slight intimal defects from the penetrated filter legs.The exact reason cannot be determined, but 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 retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.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 medical will continue to monitor for similar events.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.H3 other text : exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Patient code: 2135 - perforation of vessels.Device code:3191 ¿ no code available, for perforation of vessel.Summary of investigational findings: complaint was reopened due to additional information received on 28feb2018.On date of retrieval 250 days post-procedure there was evidence of filter migration and tilt was = 16 degrees.Filter legs did appear outside the column of contrast before retrieval.The physician reported major difficulty attempting to retrieve the filter.Investigation is based on event description and image review.The image review did not confirm the reported filter tilt and filter migration.However, the left lateral most primary filter leg was seen extending outside of the column of contrast by approximately 13mm, indicating penetration.The right lateral most primary filter foot also extends out of the column of contrast by approximately 4mm.The anterior most primary filter leg also extends 7mm outside of the column of contrast.These penetrations likely contributed to the difficulty in retrieving the filter, which was successful utilizing advanced techniques.Follow-up venogram demonstrated mild irregularity involving the left lateral wall of the ivc, without evidence of active extravasation.The irregularity was likely due to slight intimal defects from the penetrated filter legs.The exact reason cannot be determined, but 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 retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.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 medical will continue to monitor for similar events.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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Additional information received on 10may2018: on (b)(6) 2017 (120 days post-procedure), a ct of the abdomen and pelvis with iv contrast was performed and revealed no evidence of thrombus in ivc or pelvic veins.There was thrombus present in the bilateral lower extremities.There was no evidence of filter fracture, deformation, embolization, or migration.Filter tilt was not assessed (site queried).A grade 2 filter leg interaction with the ivc wall was noted.
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Manufacturer Narrative
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Investigation is still in progress.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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Description of event according to study: during the index procedure on (b)(6) 2017, the patient received a günther tulip filter.The primary reason for filter placement was a current deep vein thrombosis with a contraindication to anticoagulation related to a recent stroke/neurological event, recent major bleeding and lupus.The inferior vena cava (ivc) diameter at the intended filter location was 22 mm.There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.Using the right internal jugular vein as the access site, a günther tulip filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe).The filter neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, migration, or extravasation of contrast after placement.Filter legs did not appear outside the column of contrast after filter placement.Filter tilt was 6 - < 11 degrees.On the same day, the post-placement x-ray was performed.There was no evidence of filter fracture, embolization, or migration.Filter tilt was 6 - < 11 degrees.On (b)(6) 2017, an ultrasound revealed a new caval thrombosis and new dvts in the right pelvic veins and right lower extremity.No treatment was required.The investigator determined that the right pelvic and lower extremity dvts were possibly related to the study device and the patient¿s pre-existing venous thromboembolic disease caused or contributed to the event.The device did not malfunction or deteriorate in characteristics or performance.Additional information received 22feb2018.The investigator determined that the caval thrombosis identified on (b)(6) 2017was possibly related to the study device and the filter placement procedure.Additional information received on 28feb2018: on (b)(6) 2018 (250 days post-procedure), the pre-retrieval x-ray was performed.There was no evidence of filter fracture or embolization.There was evidence of filter migration and tilt was = 16 degrees.On the same day, it was determined that the filter was no longer clinically needed.Filter legs did appear outside the column of contrast before retrieval.There was no thrombus present in the filter.The right internal jugular vein was used for filter retrieval.A cook 16 french sheath and tissue forceps were used to retrieve the filter.The physician reported major difficulty attempting to retrieve the filter.The filter was successfully endovascularly retrieved and there was no extravasation of contrast after retrieval.Additional information received on 10may2018: on (b)(6) 2017 (120 days post-procedure), a ct of the abdomen and pelvis with iv contrast was performed and revealed no evidence of thrombus in ivc or pelvic veins.There was thrombus present in the bilateral lower extremities.There was no evidence of filter fracture, deformation, embolization, or migration.Filter tilt was not assessed (site queried).A grade 2 filter leg interaction with the ivc wall was noted.Patient outcome: the patient remains in the study.
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Manufacturer Narrative
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.H6) ec method code: 4112 - analysis of data provided by user/third party.Summary of investigational findings: complaint reopened since a grade 2 filter leg interaction with the ivc wall was noted 120 days after filter implant.Investigation is based on a third image review: the ct scan 120 days after filter placement demonstrated interval development of two grade 2 interactions with the ivc.X-ray and venogram 250 days after filter placement did not confirm tilt or filter migration.However, the two grade 2 interactions with the ivc wall, also noted on the 120 days follow-up, were confirmed.These penetrations likely contributed to the difficulty in retrieving the filter, which was successful utilizing advanced techniques.Still 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.Summary of investigation findings of 08may2018 is still valid and remains unchanged.Cook medical will continue to monitor for similar events.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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