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

Model Number EVOLUTR-29-US

Device Problems Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Fatigue (1849); Valvular Stenosis (2697); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that six years and one month following the implant of this transcatheter bioprosthetic valve, a second transcatheter valve (non-medtronic) was implanted valve-in-valve after an echocardiogram showed leaflet thrombosis and aortic stenosis.It was reported that the patient had initially presented with fatigue and shortness of breath and anticoagulation medications were prescribed.No additional adverse patient effects were reported.

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.No images of the implantation procedure or the implanted valve were available for medtronic review and the valve was not returned to medtronic, so no product analysis could be performed.High gradients can be related to valve related factors (degeneration, thrombus, calcification, etc) or non-valve related factors (left ventricular outflow tract (lvot) obstruction, patient pressures, left ventricular (lv) dysfunction, etc).With the information available, an assignable root cause cannot be determined but the stenosis and leaflet thrombosis may have been contributing causes.Stenosis is a known potential adverse effect per the evolut instructions for use (ifu).Stenosis of bioprosthetic valves can be a manifestation of structural valve dysfunction (e.G.Calcification), thrombosis, and/or non structural dysfunction (e.G.Pannus, obstruction, etc.).Several factors can contribute to the onset and propagation of either failure mechanism such as patient medical history (age, disease stage, comorbidities, etc.), pharmacological factors, and/or intrinsic properties of the valve itself.With the information available, a conclusive root cause could not be determined.A number of factors can affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient con ditions, and its presence and rate of formation is largely dependent on patient condition.The patient did not have any pre-existing coagulopathy issues or other blood disorders.With the information available a conclusive root cause cannot be determined.Heart failure is listed in the device ifu under potential adverse events, and can be related to several factors (procedure, patient comorbidities, etc.).A conclusive relationship between the reported congestive heart failure and the device or procedure could not be determined with the information available but the stenosis and leaflet thrombosis may have been contributing causes.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.This event does not allege a device misuse or malfunction occurred.Updated data: h6 - method, results and conclusion 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.

Manufacturer Narrative

Additional information was received that the final implant depth of the medtronic valve at the index procedure was 8 mm.The medtronic valve was implanted into a native annulus.The gradient at discharge of the index procedure was not known.It was reported that following the index procedure, the patient was taking aspirin.Approximately five years, and ten months following the valve implant, a peak gradient of 46 mmhg was reported, with some degree of heart failure.Of note, the patient did not have any pre-existing coagulopathy issues or other blood disorders.No additional adverse patient effects were reported.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.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12705200
• MDR Text Key: 278596598
• Report Number: 2025587-2021-03173
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169638006
• UDI-Public: 00643169638006
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2017
• Device Model Number: EVOLUTR-29-US
• Device Catalogue Number: EVOLUTR-29-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Date Device Manufactured: 08/31/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 85 KG