W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 05/26/2021 |
Event Type
Injury
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Event Description
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The following information was received through literature ¿preventive covered stent placement at the gastroduodenal artery stump in angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy¿ published in abdominal radiology in 2021.The study aimed to evaluate the clinical outcomes of preventive covered stent placement at the gastroduodenal artery stump in patients with angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy.Between july 2006 and september 2018, a total of 25 patients were evaluated, including 15 patients underwent preventive covered stent placement at the gastroduodenal artery stump and 10 patients received conservative treatments.Viabahn devices were used for patient 8 to 15.The other patients received non-gore fluency plus stent graft (bard).Patient 14 had inferior pancreaticoduodenal artery pseudoaneurysm 1 day after the placement of the covered stent.Treatment was embolization.The patient experienced occlusion 245 days after the procedure.
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Manufacturer Narrative
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Article citation: title: preventive covered stent placement at the gastroduodenal artery stump in angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy author yuan-mao lin, et al.Https://doi.Org/10.1007/s00261-021-03123-7.Abdominal radiology (2021) 46:4995¿5006.Patient weight was unavailable.Implant date was unavailable.A review of the manufacturing records for the device was unable to be conducted as no lot number was available.The device was not returned, and information was not made available, therefore, the device was not able to be evaluated.It is unknown if these adverse events were related to the viabahn devices.Information was not made available.Cause of the event cannot be established based on the available information.Further information regarding this event was requested by gore, but no further information has been reported.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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Manufacturer Narrative
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Cbas® heparin surface incorporates carmeda 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 information was received through literature ¿preventive covered stent placement at the gastroduodenal artery stump in angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy¿ published in abdominal radiology in 2021.The study aimed to evaluate the clinical outcomes of preventive covered stent placement at the gastroduodenal artery stump in patients with angiogram-negative sentinel hemorrhage after pancreaticoduodenectomy.Between july 2006 and september 2018, a total of 25 patients were evaluated, including 15 patients underwent preventive covered stent placement at the gastroduodenal artery stump and 10 patients received conservative treatments.Viabahn devices were used for patient 8 to 15.The other patients received non-gore fluency plus stent graft (bard).Patient 14 experienced occlusion 245 days after the procedure.
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