Model Number FNAV-DS-LG |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Vascular Dissection (3160)
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Event Date 12/12/2022 |
Event Type
Death
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Event Description
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It was reported that on (b)(6) 2022, a portico valve was chosen for implant using large flexnav delivery system in a patient with aortic stenosis.During the procedure, after the delivery system had been introduced, the patient's blood pressure dropped and was unable to return to normal.It was discovered that there had been an annulus dissection, resulting in the patient passing away during the procedure.It's unknown as to when exactly the annulus dissection occurred during the procedure as the annulus rupture itself was not able to be observed on imaging.No additional information was provided.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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Subsequent to the initially filed report, the following information was received that the valve was implanted in the patient.No additional information was provided.
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Manufacturer Narrative
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An event of a drop in blood pressure and annulus dissection during the procedure resulting in death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Search Alerts/Recalls
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