Catalog Number VBJR061502A |
Device Problems
Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
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Patient Problem
No Information (3190)
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Event Date 07/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device revealed the following: the delivery catheter was returned and appeared to be unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.All information has been placed on file for use in tracking and trending.
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Event Description
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The following was reported to gore by the doctor: the patient presented for a thoracic duct case.The gore® viabahn® endoprosthesis was to be placed in the patient's lymphatic system.The gore® viabahn® endoprosthesis was placed in the trunk of the lymphatic system (in the abdomen) and advanced to the subclavian vein.A second wire was advanced from the arm to snare the gore® viabahn® endoprosthesis in the lymphatic system.The doctor reported that patient anatomy was very tortuous.When the device was positioned, the deployment line was pulled.The deployment halted at the distal end of the gore® viabahn® endoprosthesis.The doctor was unable to complete deployment of the gore® viabahn® endoprosthesis so proceeded with standard treatment of using glue and a coil to seal off the duct.The gore® viabahn® endoprosthesis remains in the patient.According to the doctor, the patient is fine.
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Manufacturer Narrative
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Additional manufacturer narrative: a1: patient identifier.G5: pre-1938.G5: otc product.
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Search Alerts/Recalls
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