MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTFX-29 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Atrial Fibrillation (1729); Heart Block (4444)
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Event Date 04/11/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id l-evolutfx-2329; product lot/serial number unknown; product type: compression loading system (cls) product id d-evolutfx-2329; product lot/serial number unknown; product type: delivery catheter system (dcs) 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 on the same day following the implant of this transcatheter bioprosthetic valve, after leaving the operating room the patient developed atrial fibrillation (afib) and had no intrinsic rhythm.The patient was dependent on a temporary pacemaker.It was determined that complete atrio-ventricular block (cavb) had occurred after the procedure.A permanent pacemaker was planned to be implanted the day after the procedure.Per the physician, left ventricular hypertrophy (lvh) was present, the left ventricular outflow tract (lvot) was narrowed and the septal membrane was about 5mm long.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.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 indicating that the permanent pacemaker was implanted four days following the valve implant.
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Search Alerts/Recalls
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