(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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On (b)(6) 2011, this 23 mm trifecta valve was implanted.On (b)(6) 2017, a valve-in-valve was performed due to aortic insufficiency which was reported to be due to a torn leaflet.The size and type of tavi valve implanted is unknown.The patient was reported to be in stable condition.
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