MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTR-34 |
Device Problems
Device Dislodged or Dislocated (2923); Central Regurgitation (4068)
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Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 03/14/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id: envpro-16 (lot: 0011812806); product type: delivery catheter system (dcs).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve, the valve dislodged towards the direction of the left ventricle, resulting in unspecified aortic insufficiency.An attempt was made to move the valve higher using a snare.As the valve position was moved higher, the ai was still present.A 26 mm non-medtronic vacs balloon was used to expand the valve in the hope that the ai would resolve.This was not the case.An attempt was made to move the valve higher again.The valve dislodged.The valve was relocated to the ascending aorta and held in place with a snare.A non-medtronic sapient was implanted with a successful result.No additional adverse patient effects were reported.
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Event Description
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Additional information was received which reported that a pre-implant balloon aortic valvuloplasty (bav) was not performed.The cause of the dislodge was not known.The severity of the ai present following the dislodgement was classified as severe.
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Manufacturer Narrative
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Updated 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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