Device Problem
Complete Blockage (1094)
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Patient Problem
Occlusion (1984)
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Event Date 06/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.Note: this event was originally reported to fda in medwatch #2017233-2019-00481 & #2017233-2019-00483.This report addresses the non specific device occlusion of the same event.
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Event Description
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The following was reported to gore: on an unknown date, a biliary metallic stent (mfg unknown) was placed to treat unresectable pancreatic head cancer.The patient also received chemotherapy at that time.After treatment, the patient vomited blood frequently.Pseudoaneurysm in the proximal part of superior mesenteric artery associated with infection was observed by the doctor.To treat the pseudoaneurysm, a gore® viabahn® endoprostheses was placed and dual antiplatelet therapy (dapt) was performed.Over the course of treatment, a second gore® viabahn® endoprostheses was implanted.On an unknown date ct revealed occlusion of the gore® viabahn® endoprostheses and air was observed inside/outside of the gore® viabahn® endoprostheses.The doctor confirmed that mesenteric ischemia was not present.Biliary metallic stent breakage was also observed at this time.The doctor reported that the biliary metallic stent break contributed to occlusion of the gore® viabahn® endoprostheses.Symptoms of infection were noted and the patient was discharged from the hospital with the absence of any bleeding.
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Manufacturer Narrative
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Corrected data:
b3 - date of event.
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Manufacturer Narrative
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Corrected data: g5 - combination product, g5 - pre-1938, g5 - otc product.
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Manufacturer Narrative
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Additional manufacturer narrative: b7 - other relevant history, including preexisting medical conditions.D5 - operator of device.G5 - combination product.G5 - pre-1938.G5 - otc product.Two gore® viabahn® endoprostheses were involved in this reported event.See manufacturer report # 2017233-2019-00696.
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Search Alerts/Recalls
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