MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTFX-26 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id: d-evolutfx-2329 (lot: 0012033691), product type: 0195-heart valves.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, two deployment attempts were made due to positioning difficulties.After the valve was fully deployed, a dislodge occurred.The valve was kept implanted in the patient, and a second valve (b)(6) was implanted successfully.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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