W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Model Number HT087080A |
Device Problem
Material Separation (1562)
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Patient Problems
Hemorrhage/Bleeding (1888); No Code Available (3191)
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Event Date 12/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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) 2020, the patient presented with an unknown etiology in the femoral artery and underwent treatment utilizing a gore® propaten® vascular graft.The physician completed the implanting procedure successfully.While the patient was in post operative recovery, it was observed that the gore® propaten® vascular graft had reportedly torn above the distal anastomosis post operatively.Further information has been requested but is not available at this time.
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Manufacturer Narrative
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The following fields were updated to reflect additional information received: h6: clinical code, impact codes, type of investigation, investigation findings and investigation conclusions updated to reflect additional information received and completion of investigation.
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Event Description
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The following was reported to gore: on (b)(6) 2020, the patient presented with peripheral arterial disease in the femoral arteries and underwent an aortobifemoral bypass utilizing a gore® propaten® vascular graft.The physician completed the implanting procedure successfully.While the patient was in post operative recovery, it was observed that the patient was bleeding and was taken back to the operating room.The physician observed that the gore® propaten® vascular graft appeared torn from the anastomosis in the profunda post operatively.The physician made the following observations: part of the gore® propaten® vascular graft was still connected to the artery, and when the gore® propaten® vascular graft reportedly broke it retracted back into the tunnel that was created for placement.The physician then decided to ligate the gore® propaten® vascular graft and closed off the profunda.The procedure was completed by performing an above knee amputation.The patient tolerated the procedure and is reported to be recovering.
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