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 Problems
Unspecified Tissue Injury (4559); 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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Section d references the main component of the system.Other medical products in use during the event include: product id: d-evolutfx-2329; lot #: unknown; ubd: unknown; udi#: unknown product id: l-evolutfx-2329; lot #: unknown; ubd: unknown; udi#: unknown.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, the valve was successfully implanted at a depth of 0 mm.Upon the removal of the pigtail catheter, the valve dislodged into the ascending aorta.Using a snare, the valve was pulled up into the ascending aorta, and a non-medtronic valve was successfully deployed in the annulus.A procedural delay of two hours was reported.The patient was stable, and no additional adverse patient effects were reported.
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Manufacturer Narrative
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Updated data: a3b.Patient gender added corrected data: h6.Patient code e2015 removed 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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