Catalog Number ECH460045J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ischemia (1942)
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Event Date 11/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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Review of device manufacturing record history confirmed device met pre-release specifications.The explanted device was discarded at user facility.Therefore, direct product analysis was not possible.
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Event Description
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The following was reported to gore: in (b)(6) 2018 (exact date unknown), a patient was implanted with a gore® acuseal vascular graft in the patient's left upper arm as an arteriovenous shunt for hemodialysis.On (b)(6) 2018, an explant procedure was performed due to suspected arterial steal syndrome.The patient underwent artery superficialization method and the arterial steal symptom was resolved.
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Event Description
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On (b)(6), arterial steal syndrome was suspected.On (b)(6), intervention was performed.
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Manufacturer Narrative
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B3: date of event was corrected to onset date instead of intervention date.B5: event description updated.
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Search Alerts/Recalls
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