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

Model Number EVOLUTR-34-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Death (1802)

Event Date 06/23/2020

Event Type  Death  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, into a patient with a dilated aortic root, when the valve was released, an aortic dissection occurred.No treatment was provided.One day following the valve implant, the patient died.The cause of death was an aortic dissection caused by the valve.It is unknown whether an autopsy was performed.

Manufacturer Narrative

Conclusion: the device history record of the valve 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.Cardiovascular injuries, including dissection, are known potential adverse patient effects per the evolut system instructions for use (ifu), and may be impacted by many factors including the patient's pre-procedural condition, anatomical factors, in addition to procedural and device factors.It was reported that the patient had a dilated aortic root, therefore, patient anatomy may have played a role in the dissection.Patient death and dissection are also known potential adverse effect per the evolut system instructions for use (ifu).Based on the limited information available, and no images provided to medtronic for review, the root cause of the dissection and the subsequent death, cannot be determined and the relationship to the valve could not be established.However, there was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Updated information: h.6 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.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10265216
• MDR Text Key: 198554949
• Report Number: 2025587-2020-02218
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000017682
• UDI-Public: 00763000017682
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: EVOLUTR-34-US
• Device Catalogue Number: EVOLUTR-34-US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR