MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-29US |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Non specific EKG/ECG Changes (1817); Numbness (2415); Spinal Cord Injury (2432)
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Event Date 02/16/2023 |
Event Type
Injury
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Event Description
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Medtronic received information that prior to implant of this transcatheter bioprosthetic valve, the patient had a severe hunchback a nd underwent the transcatheter aortic valve replacement (tavr) procedure.During the procedure, an unspecified heart block occurred and temporary pacing was used.Subsequently, the heart block was no longer present after the implant of the valve.The pacemaker lead was removed.3 days following the implant of the valve, during post-operative rehabilitation, numbness in both lower legs and dif faculty walking was observed.Upon consultation with an orthopedic surgeon, an magnetic resonance imaging (mri) was performed that revealed a spinal cord infarction.It was decided to proceed with rehabilitation.15 days later, the numbness improved.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Select patient information cannot be included in the regulatory report due to regional privacy regulations.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.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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