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
Non specific EKG/ECG Changes (1817); Heart Block (4444)
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Event Date 04/18/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id d-evolutfx-2329 (lot: 0012050581); product type: 0195-heart valves product id l-evolutfx-2329 (lot: 0012033766); 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 implant of this transcatheter bioprosthetic valve, the patient had a right bundle branch block (rbbb) and first degree atrio-ventricular (av) block which progressed to a complete av block during the surgery.The patient was put on follow-up observation.No additional adverse patient effects were reported.
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Event Description
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Additional information was received that no permanent pacemaker was implanted.
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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.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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