MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTFX-29 |
Device Problems
Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
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Patient Problem
Vascular Dissection (3160)
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Event Date 04/08/2024 |
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: brand name evolut fx dcs; product id d-evolutfx-2329 (unknown serial/lot); 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, upon first deployment attempt, the valve was recaptured due to shallow implant depth.Before the team had the chance to recapture, the valve dislodged aortically.The valve was recaptured and deployed successfully.At this point, the patient's blood pressure dropped.Echocardiogram and angiogram confirmed the presence of an aortic dissection.The patient remained stable as the operating room (or) team was assembled for aortic dissection repair.The patient was taken to the or for surgical repair.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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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Additional information was received that it is unknown if the dissection occurred during recapture or deployment and it is unknown what caused the dissection.
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Manufacturer Narrative
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Other medical products in use during the event include: brand name evolut fx dcs; product id d-evolutfx-2329 (lot: 0012109269); 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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Search Alerts/Recalls
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