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

Model Number EVPROPLUS-34US

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficiency, Valvular (1926); Heart Block (4444)

Event Date 10/23/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: the valve remains implanted therefore no product analysis can be performed.Conclusion: without 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 following the implant of this transcatheter bioprosthetic valve, which was implanted low in the left ventricular outflow tract (lvot), moderate paravalvular leak (pvl) was noted.A snare was used and the valve was pulled from the lvot and beyond the annulus.The valve was left in the ascending aorta and a second valve was successfully implanted in the annulus.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information was received which indicated that one day after the valves were implanted, a permanent pacemaker was implanted due to complete heart block (chb).Two days after the valves were implant, it was reported that the patient died.Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: evproplus-34us, serial #: (b)(6), ubd: 2022-04-18, udi#: (b)(4).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 valve did not cause or contribute to the death.Rather, the death was due to a perforation caused by a pacing lead.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: no images were available, so no image review could be performed and the paravalvular leak (pvl) could not be confirmed.It was unknown if an autopsy was performed, but an explant was not.Thus, the valve remained implanted and was not returned to medtronic for product analysis.Pvl is a known potential adverse effect per the device instructions for use (ifu) and can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.In this case, a conclusive root cause could not be determined from the limited information available, but the valve being deployed low and into the left ventricular outflow tract (lvot) was a likely contributing cause.Conduction disturbances, such as complete heart block (chb), are known potential adverse effects per the device ifu, and can be resolved with the implant of a permanent pacemaker with the risk-benefit ratio in favor of the transcatheter aortic valve.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations.A conclusive cause could not be determined from the limited information available.With the limited information available, there appears to be no relationship between the device and the death.Per the physician, the cause of patient death was pacer lead perforation and the valve did not cause or contribute to the death.No further action is recommended at this time.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.

• Brand Name: EVOLUT PRO PLUS 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: 10771076
• MDR Text Key: 214131739
• Report Number: 2025587-2020-03385
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211158
• UDI-Public: 00763000211158
• 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,Followup,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2022
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 87