W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Model Number HT066080A |
Device Problem
Material Separation (1562)
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Patient Problem
Unspecified Vascular Problem (4441)
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Event Date 01/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in 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 an unknown date (7months ago) a gore® propaten® vascular graft (vg) was placed in the superficial femoral artery for treatment of occlusion.On (b)(6) 2021, a gore® viabahn® endoprosthesis (vsx) was placed in the common iliac for treatment of stenosis.The physician was unable to gain access in the upper arm due to the diseased state of the patient's vessels.So the physician decided to gain access from the vg that was previously implanted (on an unknown date).The physician cut down into the vg and inserted a 7fr introducer sheath.The vsx was successfully deployed in the native vessel above the vg device in the common iliac.The patient did not experience any adverse consequences.On (b)(6) 2021, the patient had low ankle-brachial index (abi) and an ultra sound was performed.It was noticed that the low abi was coming from the vg and what appeared to be a separation of the graft's inner lumen.On (b)(6) 2021, the decision was made to reline the vg with a 6mm x 25cm vsx.The patient did not experience any adverse consequences.
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Manufacturer Narrative
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H6 - investigation findings, code updated to 3221 (no findings available).H6 - investigation conclusions, code updated to 4315 (cause not established).
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Manufacturer Narrative
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Corrected h6 - component code.
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Search Alerts/Recalls
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