W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Catalog Number ECH060040W |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
Vascular Dissection (3160)
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Event Date 10/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient weight information was not made available.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Event Description
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The following was reported to gore: on (b)(6) 2021, a patient was implanted with a gore® acuseal vascular graft during a arteriovenous graft (avg) procedure.The graft anastomosis was brachial artery and median cubital vein.During the postoperative follow-up on (b)(6) 2021, it was found there was dissection at anastomotic site of graft in the area of arteriovenous puncture and vein segment passing through the elbow joint, which led to thrombosis.It was also found vcuseal vascular graft silica gel layer delamination at same area.Physician suspected that the dissection/thrombosis/device delamination might be caused by two issues, one was that the tunneler (u type) used during initial procedure was not appropriate, the other was that the puncture operation may hurt vascular graft during hemodialysis as the patient had kidney disease.The vcuseal vascular graft was removed and another non-gore vascular graft (maquet) was used to complete the procedure on (b)(6) 2021.The patient tolerated procedure.
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Manufacturer Narrative
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A review of the manufacturing records, indicated the lots met all pre-release specifications.Due to no device and no imaging return, an evaluation could not be performed.
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Manufacturer Narrative
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H6: add component code.B5: describe event or problem - correction of the wording from "vcuseal" to "acuseal".
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Event Description
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The following was reported to gore: on (b)(6) 2021, a patient was implanted with a gore® acuseal vascular graft during a arteriovenous graft (avg) procedure.The graft anastomosis was brachial artery and median cubital vein.During the postoperative follow-up on (b)(6) 2021, it was found there was dissection at anastomotic site of graft in the area of arteriovenous puncture and vein segment passing through the elbow joint, which led to thrombosis.It was also found acuseal vascular graft silica gel layer delamination at same area.Physician suspected that the dissection/thrombosis/device delamination might be caused by two issues, one was that the tunneler (u type) used during initial procedure was not appropriate, the other was that the puncture operation may hurt vascular graft during hemodialysis as the patient had kidney disease.The acuseal vascular graft was removed and another non-gore vascular graft (maquet) was used to complete the procedure on (b)(6) 2021.The patient tolerated procedure.
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