MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTPRO-26-US |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: ev olutpro-26-us, serial/lot #: (b)(4), product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during the implant of this 26 mm transcatheter bioprosthetic valve, the valve dislodged following release.A second, 23 mm transcatheter valve was implanted.However, following the implant of the replacement valve, an aortic dissection was reported.The procedure was converted to a surgical thoracotomy.The two transcatheter valve were explanted, and a mechanical valve was implanted.It was reported that the patient was in good condition.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that the valve was deployed at a shallow implant depth and upon full deployment, it dislodged.The aortic dissection was caused during the second valve implant.It was reported that the delivery catheter system (dcs) pushed the first valve forward.The dissection was repaired during the surgical thoracotomy with a suture repair.Section d information references the main component of the system.Other relevant device(s) are: product id envpro-16-us, lot 0011020404, use by date 2024-01-13, udi (b)(4).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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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