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

Model Number EVOLUTR-29

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Ischemia Stroke (4418)

Event Date 01/04/2023

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: the main component of the system.Other relevant device(s) are: product id: evolutr-29, serial/lot #: (b)(4), ubd: 15-jan-2023, udi#: (b)(4).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.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 following the implant of this transcatheter bioprosthetic valve, the implantation was uneventfully via left subclavian artery by puncture due to lack of transfemoral access.Approximately two hours following the implant of this transcatheter bioprosthetic valve, a cerebral angiography was performed via right radial artery and a stroke was observed.In an attempt to access the left carotid artery, a 0.035 guidewire was used which interacted with the valve outlet.The valve dislodged to the ascending aorta.The patient became hypotensive and urgent transcatheter aortic valve implantation (tavi) was performed with the same size valve via left carotid dissection.At 80% deployment of the valve, contrast was injected and flow was observed in both coronary arteries.After releasing the valve, occlusion of the left coronary artery occurred.The patient went into cardiac arrest and was not responding to resuscitation measures.After 30 mins of resuscitation attempts the patient died.The physicians were unable to access the left coronary artery.

Manufacturer Narrative

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

Additional information was received which reported that the stroke was confirmed via a neurological examination.The stroke was ischemic in nature.As a result of the stroke, the patient experienced lowered sensory.According to the physician, the stroke was related to the valve implantation, as the patient had many co-morbidities and poor access.It was reported that the patient's calcified anatomy and the subclavian access site contributed to the stroke.According to the physician, the cause of the left coronary occlusion was not clear, however the valve frame contributed.With the first valve implant, there were no complications in relation to the coronaries and according to the angio tomography images, there was no indication of coronary protection.The documented cause of death was a heart attack.Corrected information indicated that the "via the left carotid by dissection" was in regards to a form of access, replacing a puncture it was not a complication.

Manufacturer Narrative

Conclusion: the valve was not returned to medtronic, so no product analysis could be performed.No images were provided for review.A medical safety assessment was performed.The results are as follows: upon review of the information provided, the event of valve dislodgement is assessed as not related to the evolut r valve.The valve dislodged during a cerebral angiogram for a confirmed ischemic stroke, where the guidewire interaction with the valve outlet causing it to dislodge.The event of coronary artery occlusion and death are assessed as likely related to the evolut r valve, as after deployment of the 2nd valve (which was also an evolut r valve), coronary artery occlusion was noted resulting in an myocardial infarction (mi) and subsequently death.Coronary artery access was not able to be obtained.Dislodgement, coronary artery occlusion, unplanned intervention and death are known potential risks associated with the implantation of the evolut r valve and all reported adverse events and severities are documented in our risk files and instructions for use (ifu).No further safety assessment is required at this time.Per ifu, coronary occlusion is listed as a potential risk associated with the implantation of the device and it can be attributed to procedural factors (e.G., valve positioning, sizing, technique, etc.) and/or anatomical factors (e.G., location of coronaries with respect to the valve, height of ostia, etc.).The valve dislodgement may have been a contributing factor in the occlusion.Cardiac arrest is a known potential adverse effect per device ifu.In this case, a conclusive cause could not be determined from the limited information available.Myocardial infarction is a known potential adverse effect per device ifu.The mi is likely related to a patient condition, however a conclusive cause could not be determined from the limited information available.The occlusion is likely a contributing factor.The death was reported to be result of the myocardial infarction.Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a tav is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.The cause of death was reported to be a heart attack.Review of the device history record (dhr) were performed for this device found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.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.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: potential factors that can influence a dislodged valve include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, compliance of the aorta and native vessels, and a number of others.In this case, a balloon aortic valvuloplasty (bav) was performed.Based on the information made available, the guidewire interacted with the valve during implant, causing the dislodge.This is a use-related cause.Stroke is a known potential adverse effect per the device instructions for use (ifu), with a variety of factors that can influence its onset.In this case, no definite root cause can be assigned to the stroke.However, according to the physician, the stroke was related to the valve implantation, as the patient had many co-morbidities and poor access.It was also reported that the patient's calcified anatomy and the subclavian access site contributed to the stroke.Hypertension is a known potential adverse effect per the device ifu, with a variety of factors that can influence its onset.Due to the limited information available, a conclusive root cause could not be determined.There is no information to suggest a device quality deficiency that may have caused or contributed to this.This event does not allege a device misuse or malfunction occurred.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.

• 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: 16155559
• MDR Text Key: 307256703
• Report Number: 2025587-2023-00119
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Date Device Manufactured: 01/15/2022
• 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
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Female