Catalog Number PAHR080501E |
Device Problem
Migration (4003)
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Patient Problem
Embolism (1829)
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Event Date 05/03/2018 |
Event Type
malfunction
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Event Description
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The following was reported to gore: on (b)(6) 2014, a gore® acuseal vascular graft was implanted to create a venous anastomosis between the right femoral artery and the femoral vein.On (b)(6) 2018, the patient presented with a stenosis at the venous anastomosis region.Two gore® viabahn® endoprosthesis were implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The devices bridged from the femoral vein into the gore® acuseal vascular graft.On (b)(6) 2018, follow-up imaging showed that the two gore® viabahn® endoprosthesis migrated into the pulmonary artery, now representing an embolus.The migration of the two device was not identified on the date, but it was realized on (b)(6) 2019, that the two devices must have migrated sometime before (b)(6) 2018.The ct angiogram shows patent pulmonary arteries around the migrated devices and no reintervention is currently planned.
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Manufacturer Narrative
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In total two reports were submitted for the notified medical incident with the following lot numbers: lot #17415603; (b)(4); mfr report #2017233-2019-00143, lot #17511353; (b)(4); mfr report #2017233-2019-00144.
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Event Description
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The following was reported to gore: on (b)(6) 2014, a gore® acuseal vascular graft was implanted to create a venous anastomosis between the right femoral artery and the femoral vein.On (b)(6) 2018, the patient presented with a stenosis at the venous anastomosis region.Two gore® viabahn® endoprosthesis were implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The devices bridged from the femoral vein into the gore® acuseal vascular graft.On may 03, 2018, follow-up imaging showed that the two gore® viabahn® endoprosthesis migrated into the pulmonary artery, now representing an embolus.The migration of the two device was not identified on the date, but it was realized on (b)(6) 2019, that the two devices must have migrated sometime before (b)(6) 2018.The physician assumes that the following caused or contributed to the migration of the devices: the patient has had numerous angiograms which show the venous anastomosis and none clearly show a definitive stenosis.The lack of venous stenosis as an anchor point is another potential factor in the stent-graft embolization.The larger vein in which the smaller stent-graft was deployed is another potential factor in the stent-graft embolization.Before the end of the procedure, the 8 x 50 mm stent-graft was noted to have moved up the leg and judged no longer to cover the stenosis.# insufficient anchoring of both gore® viabahn® endoprosthesis.Increased blood pressure.No actions are currently planned to remove the devices from the pulmonary artery.
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Manufacturer Narrative
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B5 and 7: updated h6: updated conclusion code case images were provided to gore for evaluation.The evaluation showed the following: - (b)(6)-2018: - series 1 at 10:06: final angiogram shows four stents deployed within a vascular graft, two in the loop portion, and two near the anastomosis.- (b)(6) 2018: - series 1 at 09:44: there appears to be two stents deployed within a vascular graft, both in the loop portion.- series 3 at 09:55: there appears to be one stent visible, this does not appear to be in loop portion of the graft.- series 5 at 10:00: there appears to be three stents deployed within a vascular graft, two in the loop portion, and one near the anastomosis.- (b)(6) 2019: - series 1 at 09:34: there appears to be two stents deployed within a vascular g raft, both in the loop portion.- ap chest x-ray at 09:46: there appears to be three stent grafts within the region of the right lung/right heart on the ap chest x-ray.
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Event Description
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The following was reported to gore: on (b)(6) 2014, a gore® acuseal vascular graft was implanted to create a venous anastomosis between the right femoral artery and the femoral vein.On (b)(6) 2018, the patient presented with a likely stenosis at the venous anastomosis region.Two gore® viabahn® endoprosthesis were implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The devices bridged from the femoral vein into the gore® acuseal vascular graft.On (b)(6) 2018, follow-up imaging showed that the two gore® viabahn® endoprosthesis migrated into the pulmonary artery, now representing an embolus.The migration of the two device was not identified on the date.It was realized on (b)(6), 2019, that the two devices must have migrated sometime before (b)(6) 2018.The ct angiogram dated shows patent pulmonary arteries around the migrated devices.No actions are currently planned to remove the devices from the pulmonary artery.The physician provided the following theories as possible causes for the migration of the devices gore® viabahn® endoprostheses: - lack of anchor within the 6 mm portion of the gore® acuseal vascular graft.- the lack of venous stenosis as an anchor point.The patient has had numerous angiograms which show the venous anastomosis and none clearly show a definitive stenosis.- a larger vein in which the smaller gore® viabahn® endoprosthesis was deployed.- before the end of the procedure, the 8 x 50 mm gore® viabahn® endoprosthesis was noted to have moved up the leg and judged no longer to cover the stenosis.A second stent-graft was placed (7 x 50 mm gore® viabahn® endoprosthesis) to cover the stenosis.Though this stent-graft overlapped the first inserted stent-graft, its smaller caliber relative to the first stent-graft means it would not have anchored this first stent-graft in place.- at dialysis, venous return can be done at different rates.One of these rates is very fast, intended for use when the patient has symptomatic hypovolemia while on dialysis.The increased pressure of this blood may have contributed to the device migration.
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Manufacturer Narrative
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Gore event 39551 (medwatch 2017233-2019-00144 and 2017233-2019-00143) reflects the two gore® viabahn® endoprosthesis that were implanted on (b)(6) 2018 and that migrated before (b)(6) 2018.- gore event 39602 (medwatch 2017233-2019-00145) reflects the one additional gore® viabahn® endoprosthesis that was implanted on (b)(6) 2018 and that must have migrated before (b)(6) 2019.
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Event Description
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The following was reported to gore: on (b)(6) 2016, a gore® acuseal vascular graft was implanted to create a bypass between the right femoral artery and the femoral vein.It was stated that the outflow was stent grafted.On (b)(6) 2018, the patient presented with a likely stenosis at the venous anastomosis region.Two gore® viabahn® endoprosthesis were implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The devices bridged from the femoral vein into the gore® acuseal vascular graft.On (b)(6) 2018, follow-up imaging showed that the two gore® viabahn® endoprosthesis migrated into the pulmonary artery, representing an embolus.It was realized on (b)(6) 2019, that the two devices must have migrated sometime before (b)(6) 2018.The ct angiogram dated shows patent pulmonary arteries around the migrated devices.No actions are currently planned to remove the devices from the pulmonary artery.The physician provided the following theories as possible causes for the migration of the devices gore® viabahn® endoprostheses: lack of anchor within the 6 mm portion of the gore® acuseal vascular graft.The lack of venous stenosis as an anchor point.The patient has had numerous angiograms which show the venous anastomosis and none clearly show a definitive stenosis.A larger vein in which the smaller gore® viabahn® endoprosthesis was deployed.Before the end of the procedure, the 8 x 50 mm gore® viabahn® endoprosthesis was noted to have moved up the leg and judged no longer to cover the stenosis.A second stent-graft was placed (7 x 50 mm gore® viabahn® endoprosthesis) to cover the stenosis.Though this stent-graft overlapped the first inserted stent-graft, its smaller caliber relative to the first stent-graft means it would not have anchored this first stent-graft in place.At dialysis, venous return can be done at different rates.One of these rates is very fast, intended for use when the patient has symptomatic hypovolemia while on dialysis.The increased pressure of this blood may have contributed to the device migration.
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Manufacturer Narrative
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B5: updated.
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Search Alerts/Recalls
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