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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP
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W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP Back to Search Results
Catalog Number PAHR070501E
Device Problem Migration (4003)
Patient Problem Embolism (1829)
Event Date 01/31/2019
Event Type  malfunction  
Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
 
Event Description
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.A gore® viabahn® endoprosthesis was implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The device bridged from the femoral vein into the gore® acuseal vascular graft.The device was placed at exactly the same location as two previous gore® viabahn® endoprostheses that had migrated into the pulmonary artery before (b)(6) 2018.On (b)(6) 2019, follow-up imaging revealed that the additional implanted gore® viabahn® endoprosthesis had also migrated into the pulmonary artery, now representing an embolus.It was stated that the ct angiogram shows patent pulmonary arteries around the three migrated devices.
 
Manufacturer Narrative
B5: updated event description.G5: updated.H6: added method code.
 
Event Description
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.A gore® viabahn® endoprosthesis was implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The device bridged from the femoral vein into the gore® acuseal vascular graft.The device was placed at exactly the same location as two previous gore® viabahn® endoprostheses that had migrated into the pulmonary artery before (b)(6) 2018.On (b)(6) 2019, follow-up imaging revealed that the additional implanted gore® viabahn® endoprosthesis had also migrated into the pulmonary artery, now representing an embolus.It was stated that the ct angiogram shows patent pulmonary arteries around the three migrated devices.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.
 
Manufacturer Narrative
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.
 
Event Description
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.A gore® viabahn® endoprosthesis was implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The device bridged from the femoral vein into the gore® acuseal vascular graft.The device was placed at exactly the same location as two previous gore® viabahn® endoprostheses that had migrated into the pulmonary artery before (b)(6) 2018.On (b)(6) 2019, follow-up imaging revealed that the additional implanted gore® viabahn® endoprosthesis had also migrated into the pulmonary artery, now representing an embolus.It was stated that the ct angiogram shows patent pulmonary arteries around the three migrated devices.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.During the procedure on (b)(6) 2018, a third 7 x 50 mm gore® viabahn® endoprosthesis was inserted in the same location as the previous stent-grafts.At this stage, two interim angiograms had occurred at which the original two stent-grafts were absent but this was not recognized.The risk of embolization for the same reasons as the other stent-grafts, above.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.No actions are currently planned to remove the devices from the pulmonary artery.
 
Manufacturer Narrative
B1: corrected to product problem.B5: updated.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 may 03, 2018.Gore event 39602 reflects the one additional gore® viabahn® endoprosthesis that was implanted on october 25, 2018 and that must have migrated before january 31, 2019.
 
Event Description
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 stenosis at the venous anastomosis region.A gore® viabahn® endoprosthesis was implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The device bridged from the femoral vein into the gore® acuseal vascular graft.The device was placed at exactly the same location as two previous gore® viabahn® endoprostheses that had migrated into the pulmonary artery before may 03, 2018.On (b)(6) 2019, follow-up imaging revealed that the additional implanted gore® viabahn® endoprosthesis had also migrated into the pulmonary artery, now representing an embolus.It was stated that the ct angiogram shows patent pulmonary arteries around the three migrated devices.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.During the procedure on (b)(6) 2018, a third 7 x 50 mm gore® viabahn® endoprosthesis was inserted in the same location as the previous stent-grafts.At this stage, two interim angiograms had occurred at which the original two stent-grafts were absent but this was not recognized.The risk of embolization for the same reasons as the other stent-grafts, above.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.No actions are currently planned to remove the devices from the pulmonary artery.
 
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Brand Name
GORE VIABAHN® ENDOPROSTHESIS - 3
Type of Device
NIP
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key8419512
MDR Text Key138762162
Report Number2017233-2019-00145
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
PMA/PMN Number
P130006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup,Followup
Report Date 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/24/2021
Device Catalogue NumberPAHR070501E
Device Lot Number18397219
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age46 YR
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