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

Model Number EVPROPLUS-26US

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Vascular Dissection (3160); Pericardial Effusion (3271); Valvular Insufficiency/ Regurgitation (4449)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 prior to the implant of this transcatheter bioprosthetic valve, a pre-implant balloon aortic val vuloplasty (bav) was performed using a 16 mm balloon.At that time, the non-coronary cusp (ncc) leaflet fell into the left ventricle, resulting in severe aortic regurgitation (ar).The patient's pressure was 50/30.The valve was hastily implanted.The patient's blood pressure did not recover, therefore percutaneous cardiopulmonary support (pcps) was prepared.The valve seemed to have dislodged to due cardiopulmonary resuscitation (cpr) but did not fully pop out.Pcps was placed.The patient's pressure returned to a certain level, and an echocardiogram was performed.Moderate paravalvular leak (pvl) was observed, therefore a post implant bav was performed.The blood pressure was reported as 140/58.The pvl had reduced to mild or less.A pericardial effusion was observed when the valve placement was re-evaluated.A pericardial puncture was performed.Heart contractions were confirmed via echography.Computed tomography (ct) imaging in the "hor" revealed a dissection from the ncc to the ascending aorta.The patient was placed under observation, but it was later reported that although the effusion was temporarily improved as a result of the dissection, it did not resolve.A thoracotomy was performed.An aortic valve replacement was performed.It was reported that cardiac function improved and the patient was placed back under observation.No additional adverse patient effects were reported.

Event Description

Additional information was received which reported that the patient experienced cardiogenic shock due to the acute ar followed by the pre-implant bav.The ncc leaflet fell into the lv as a result of the pre-implant bav.During placement of the valve, cardiopulmonary arrest (pea) developed.Compressions were applied and the patient was placed on extracorporeal membrane oxygenation (ecmo).Cardiac tamponade resulted from the pericardial effusion.The physician commented that the valve frame might have damaged the inner wall during the cardiac compressions//cardiopulmonary resuscitation (cpr).During the thoracotomy, the transcatheter valve was explanted, an aortic valve repair and an ascending aorta replacement surgery were performed.No additional adverse patient effects were reported.

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.

Manufacturer Narrative

Updated data: b2.B5.H1.H6.Corrected data: h4.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received that persistent hypoxic encephalopathy associated with acute aortic dissection and cardiac tampo nade were observed as a post-operative complication of the transcatheter aortic valve replacement (tavr) procedure.4 months and 24 days following the implant of the valve, the patient died of heart failure.Per the physician, the valve and the valve implant procedure were causal/contributing factors to the death.

• Brand Name: EVOLUT PRO PLUS 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: 16097880
• MDR Text Key: 306649225
• Report Number: 2025587-2023-00028
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: EVPROPLUS-26US
• Device Catalogue Number: EVPROPLUS-26US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2023
• 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): Life Threatening; Hospitalization; Required Intervention; Death