MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-23US |
Device Problem
Migration (4003)
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Patient Problems
Chest Pain (1776); Obstruction/Occlusion (2422)
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Event Date 05/09/2022 |
Event Type
Injury
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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve (sn unknown pli 10), during expansion, the valve did not expand."influencing" occurred.The valve was exchanged.The replacement valve was implanted.After the procedure was completed, and the patient was returning to the intensive care unit (icu), chest pain was reported.A reduction in coronary blood flow due to the valve was suspected.Valve migration was reported.An emergency thoracotomy was performed.The valve was explanted and a surgical aortic valve was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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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Manufacturer Narrative
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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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Additional information was received that during the first valve implant, the reported "influencing" refers to the valve infolding that occurred.The infolded valve was recaptured and retrieved from the patient.The final implant depth of the second valve was 1 millimeter (mm) on the non-coronary cusp (ncc) and about 2 mm on the left coronary cusp (lcc).The valve was explanted restoring blood flow to the coronaries.Of note, the patient was reported to be in good condition following the successful valve explant/surgical valve implant.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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