MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTR-34-C

Device Problems Gradient Increase (1270); Material Split, Cut or Torn (4008)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn 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.

Event Description

Medtronic received information that prior to the implant of the transcatheter bioprosthetic aortic valve the native aortic valve gra dient measured 41 millimeters of mercury (mmhg).Following the transcatheter valve implant, at discharge, the gradient measured 8.4 mmhg.Approximately 5 years and 3 months following the implant of this transcatheter aortic valve, the patient presented with fatigue, lightheadedness, and low blood pressure.A heart murmur was identified, and an echocardiogram showed an abnormal gradient.The doppler measurements provided included a mean gradient of 7.3 mmhg, a maximum velocity of 1.7 meters/second (m/s).The left atrium was dilated.No patent foramen ovale (pfo) present.No evidence of a left atrial appendage thrombus.A preliminary transesophageal echocardiogram (tee) noted a reduced left ventricular (lv) systolic function.The left ventricular ejection fraction (lvef) measured approximately 40-45%.There was moderate mitral valve regurgitation.The transcatheter valve was reported as well positioned.A flailing anterior prosthetic leaflet was observed which resulted in severe, posteriorly directed aortic regurgitation.It was also reported, there was central aortic regurgitation holodiastolic flow reversal in the descending thoracic aorta.The pressure half time (pht) was reported as <(><<)> 200 milliseconds (ms).No obvious vegetations or stenosis were visualized.There was no evidence of an aortic dissection.The patient was sent to the emergency room and subsequently admitted to the hospital.A transesophageal echocardiogram (tee) performed 2 days later noted a prosthetic leaflet dysfunction with severe aortic regurgitation (ar).The following measurements were provided: left ventricle mean 41.1 cm/s, av p1/2t, 110 milliseconds (ms) velocity, left ventricular max velocity of 76.2 centimeters/second (cm/sec), left ventricular velocity time integral of 12.5 cm, av max 175.7 velocity cm/sec, av velocity time interval 32.8 cm, av mean 7.3 mmhg, av max 12.4 pg mmhg, and aortic valve velocity ratio 0.43.Five days later, an operative report also c onfirmed severe aortic insufficiency due to a perforated leaflet and a non-medtronic valve was implanted valve-in-valve.Following the valve intervention, regurgitation was absent and the mean gradient measured 6.0 mmhg.Transthoracic echocardiography showed a peak velocity across the aortic valve of 1.7 m/s, a peak gradient of 11 mmhg, and a mean gradient of 6 mmhg.The calculated aortic valve area (ava) was 1.9 cm2.The dimensionless index was 0.56.The ejection fraction was 55%.The patient was discharged the next day.No additional adverse patient effects were reported.

Manufacturer Narrative

B5 - additional information reported that this transcatheter bioprosthetic valve was initially implanted at a depth of 2mm at the no n-coronary cusp (ncc) and 4mm at the left coronary cusp (lcc).The mild to moderate mitral regurgitation was present prior to the implant of the valve.Added b6.Laboratory data.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.

Manufacturer Narrative

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.Review of the returned transesophageal echocardiogram (tee) images confirmed abnormal leaflet motion with poor coaptation noted, with a possibly flailing prosthetic leaflet.The tee also confirmed a mildly reduced ejection fraction of 40-45% as stated in the event description.With moderate mitral regurgitation.This image review also read that there was severe transvalvular aortic regurgitation with pressure half time (pt) of 75ms.Unfortunately the valve remains implanted and is unable to be returned for analysis.There were no images received of the index procedure where the valve was implanted 5 years and three months ago, and no information whether the user had performed a balloon aortic valvuloplasty (bav) during this index procedure.If the user had performed a bav using a non compliant balloon catheter, this may have been the initial cause for the reported flailing / torn leaflet that then most likely led to unacceptable hemodynamic, hypotension, central regurgitation and heart failure.So unfortunately, with the limited information we are unable to conclusively determine the exact cause for the flailed leaflet / cuspal tear.In this event, it was reported that 5 years, 3 months and five days later approximately from the original index valve implant, the patient underwent a valve in valve with a non medtronic valve, which reduced the gradient to 6mmhg, the ejection fraction was 55%, the regurgitation was absent and the calculated aortic valve area was with 1.9cm2, with no additional adverse patient effects reported.This event does not indicate device misuse.Updated section h.6 method, result, and conclusion codes.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.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15499896
• MDR Text Key: 300739673
• Report Number: 2025587-2022-02666
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2019
• Device Model Number: EVOLUTR-34-C
• Device Catalogue Number: EVOLUTR-34-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 74 KG