MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-34US |
Device Problems
Calcified (1077); No Apparent Adverse Event (3189)
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Patient Problems
Calcium Deposits/Calcification (1758); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
Injury
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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.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 implant of this transcatheter bioprosthetic valve, plaque appeared from the sinotubular junction on the right side during the delivery of the delivery catheter system (dcs).It was reported that the pre-balloon aortic valvuloplasty (bav) with a 22 millimeter (mm) balloon may have contributed to the plaque.It was possible that the calcification of the sinotubular junction and the patient's fragile aortic wall contributed.An echocardiogram did not confirm that the plaque was scattered after passing through the dcs.After the valve was implanted, movement of the plaque was not confirmed.It was reported that the plaque was stopped by the stent.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There is no evidence to suggest the device caused or contributed to a death or serious injury.Updated data: b5 - event description h6 - patient code and device code additional codes - imf health impact code 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 the cause of the plaque movement was unknown as the plaque was not pre-existing condition.For the reported plaque stoppage by the "stent," the stent was in reference to the transcatheter bioprosthetic valve and no stent was placed.No symptoms or injury were observed as a result of the plaque movement and no treatment or intervention was performed.No adverse patient effects were reported.
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Search Alerts/Recalls
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