MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTR-34 |
Device Problems
Perivalvular Leak (1457); Material Split, Cut or Torn (4008)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Cusp Tear (2656); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 06/05/2023 |
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.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 implant of this transcatheter bioprosthetic valve, the valve implant was deep on the left coronary cusp (lcc) side.The valve was post dilated using a 27 mm non-medtronic vacs ii balloon.Severe aortic regurgitation appeared following over-dilation of the balloon.The transthoracic echocardiogram (tte) suspected a valve leaflet rupture with impaired cardiac function.The patient's aortic pressure was reported as 60/30 mmhg.A second transcatheter valve was implanted.Following the implant of the second valve, the clinical situation of the patient improved immediately.The pressure improved to 150/70 mmhg and the aortic regurgitation disappeared.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Updated b5.Updated h6.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 directly from the physician which reported that at 80% deployed, the transcatheter valve was at a depth of 2 mm on the non-coronary cusp (ncc) and 1 mm on the left coronary cusp (lcc).The valve was pulled a bit at the time of final release, and the valve jumped on the side of the ncc to 2-3 mm and a full crown on the lcc.The team performed the over-dilation because moderate paravalvular leak (pvl) was present towards the mitral valve.The semi-compliant vacs ii balloon was used with a syringe filled with 29 ml of mixed saline contrast.No pressure was recorded.After a single dilation, the central ar became present.The leaflet damage was not visualized, only suspected.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Aortic regurgitation and paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or the presence of pre-existing patient conditions.Hypotension is a known potential adverse effect per the device instructions for use (ifu).It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.In this event, it was reported that these effects occurred due to a cuspal tear resulting from an over-dilation of the post-implant balloon aortic valvuloplasty (bav).The cuspal tear was suspected, but not visualized.An over-dilation would serve as a likely cause of the reported cuspal tear.However, without imaging and based on the information available, the conclusive root cause of these events could not be confirmed.This event does not indicate device misuse or malfunction.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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