Model Number EVOLUTFX-34 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problem
Heart Block (4444)
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Event Date 04/19/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product id l-evolutfx-34 (lot: 0011957871); product type: 0195-heart valves product id d-evolutfx-34 (lot: 0011936541); 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, a complete atrio-ventricular block (cavb) occurred during the pre-implant balloon aortic valvuloplasty (bav).The cavb did not resolve during the procedure, therefore the patient left the operating room with a pacing lead in place.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 the complete atrio-ventricular block (cavb) resolved the next day after the implant procedure.No permanent pacemaker was implanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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