Model Number EVPROPLUS-26 |
Device Problems
Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Heart Block (4444); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 03/18/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id l-evprop23-29; product type: compression loading system (cls) product id d-evprop23-29; 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 day of implant of this transcatheter bioprosthetic valve, the patient had a complete heart block and moderate paravalvular leak (pvl).No treatment was performed.No additional adverse patient effects were reported.
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Event Description
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Additional information was received indicating that on the same day as the valve implant, a permanent pacemaker was implanted.
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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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Search Alerts/Recalls
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