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Model Number 40S06 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 08/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2021).
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Event Description
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It was reported through a clinical trial that approximately 1225 days post study conduit placement, there was thrombosis of vascular access.Approximately 1261 days post study conduit placement, the patient was hospitalized due to thrombosis of vascular access.Approximately 1262 days post study conduit placement, the subject underwent a thrombectomy and the event was considered resolved.The same day, the patient experienced a second thrombosis of vascular access which prolonged hospitalization.Approximately 1265 days post study conduit placement, the patient underwent a repeat thrombectomy with angioplasty.The thrombosis was resolved the same day and the patient was discharged the following day post uneventful dialysis.The current status of the patient was not provided.
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Search Alerts/Recalls
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