MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTFX-23 |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2024 |
Event Type
Death
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Event Description
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Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, a pre-implant balloon aortic val vuloplasty (bav) was performed.Following the bav, the valve was implanted at a depth of 3-4 mm on the non-coronary cusp (ncc) and 2-3 mm on the left coronary cusp (lcc); however, the valve dislodged to a depth of 6-7 mm on the ncc and lcc.Subsequently, using a snare, a second, non-medtronic valve was implanted in the annulus.A 45-minute procedural delay was reported.Following the valve implant procedure, an aortic dissection was identified, and cardiac arrest occurred.The patient required resuscitation and was taken to emergency surgery.Following surgery, dialysis was initiated, and the patient required vasopressor medications to stabilize the blood pressure.No additional adverse patient effects were reported.
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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; unknown product id: l-evolutfx-2329; 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 per the physician, the cause of the dissection was due to the valve being snared into the ascending aorta causing a small tear which worsened overtime and eventually dissected.Subsequently the valve was explanted.4 days following the valve implant procedure, the patient died.The cause of death was not reported.
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Manufacturer Narrative
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H6 additional codes.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 per the physician, the cause of death was the dissection.Per the physician, the valve could not be excluded as a contributing factor to the death, and the death was not caused by the patient¿s underlying medical history.
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Manufacturer Narrative
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Updated data: b5.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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