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

Model Number EVPROPLUS-29US

Device Problems Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 06/19/2020

Event Type  Death  

Manufacturer Narrative

The device was discarded; therefore, no product analysis can be performed.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 following the implant of this transcatheter bioprosthetic valve, the patient died.The cause of death was not reported; however, the physicians presume an aortic dissection occurred based on patient symptoms.No additional adverse patient effects were reported.It is unknown if an autopsy was performed.

Manufacturer Narrative

Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: evolut pro plus dcs, lot number: 0010137384, ubd: 2021-02-13, udi: (b)(4).Updated data: b5.Additional information was received that during the implant of this transcatheter bioprosthetic valve, the valve was recaptured due to positioning and sub-optimal depth.During valve recapture in the aorta, the patient reported chest pain but pressures were ok.The delivery catheter system (dcs) re-crossed the native valve and deployed the transcatheter valve.Chest pain remained.The dcs was withdrawn from the patient, chest pain continued then the patient's pressures started to drop.Cardiopulmonary resuscitation (cpr) was initiated and performed for forty minutes, but attempts to stabilize pressures were unsuccessful.The physicians presumed an aortic dissection occurred based on patient report of chest pain and decreasing pressures.It is unclear when the dissection occurred, but the physician noted it may have happened during recapture when the valve was pulled back into the ascending aorta.It was noted the native anatomy was calcified.An autopsy was performed and confirmed an aortic dissection which extended from the valve annulus and above.Per the physician the valve caused or contributed to the dissection and the dcs likely contributed to the dissection as well.D1.And d4.Changed the device to align with the valve.The previously reported delivery catheter system (dcs) was changed to a concomitant device.H2.The device mfg date was updated to align with the valve.H6.Patient codes: reported symptoms were added to previous codes.Device codes: updated to include positioning difficulty with the dcs.Eval code method: updated to include the valve.The valve remains implanted and the dcs was discarded; therefore, no product analysis can be performed.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 for 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.The reported event indicates the valve was recaptured due to sub-optimal positioning.Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Death and hypotension are known potential adverse effect per the evolut system instructions for use (ifu).Hypotension 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 case, the hypotension was most likely a result of the dissection.Cardiovascular injuries, including dissection, are also known potential adverse patient effects per the ifu, and may be impacted by many factors including the patient's pre-procedural condition, anatomical factors, procedural factors and device factors.It was reported that it was unclear when the dissection occurred, but the physician noted it may have happened during recapture when the valve was pulled back into the ascending aorta.It was noted the native anatomy was calcified.An autopsy was performed and confirmed an aortic dissection which extended from the valve annulus and above.Per the physician the valve caused or contributed to the dissection and the delivery catheter system (dcs) likely contributed to the dissection as well.No procedural films were received for review, and therefore the root cause cannot be confirmed, and the relationship to the valve cannot be established.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to this event.Updated data: h6 - eval method code, eval results code, eval 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.

• 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: 10279732
• MDR Text Key: 199035907
• Report Number: 2025587-2020-02240
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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
• Report Date: 10/07/2020

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: 01/28/2022
• Device Model Number: EVPROPLUS-29US
• Device Catalogue Number: EVPROPLUS-29US
• Device Lot Number: 0010137384
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 09/25/2020
• Supplement Dates FDA Received: 07/21/2020; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Age: 85 YR