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

Model Number EVOLUTFX-29

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Tachycardia (2095); Ventricular Fibrillation (2130); Rupture (2208); Obstruction/Occlusion (2422)

Event Date 01/23/2023

Event Type  Death  

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 during the implant of this transcatheter bioprosthetic valve, a pre- implant balloon aortic valv uloplasty (bav) was performed using a 25 mm non-medtronic (tyshak) balloon.As a result of the pre-dilation, an annular rupture occurred at the annular root and left ventricular outflow tract (lvot).The valve was deployed.The rupture and a coronary occlusion were observed on echocardiogram.The physician was able to place a wire into the coronary arteries.The left anterior descending, circumflex and diagonal branch coronary arteries were balloon and stented through the valve frame.The patient was placed on a balloon pump and extracorporeal membrane oxygenation (ecmo) during this time.The implanting team implanted a second, non-medtronic transcatheter valve (edwards sapien) within the first valve frame to alleviate the annular rupture.Of note, the patient was a no sternotomy/no surgery patient.As the non-medtronic transcatheter valve was put into place, the left main coronary artery was occluded again.The team needed to re-open the coronary arteries again.It was reported that it took the physician over an hour to re-access the coronary arteries through both valves.The patient was reported to be in ventricular tachycardia and ventricular fibrillation throughout the procedure and was defibrillated 21 times.The patient was placed on peripheral bypass and a trans-septal cannula was placed into the atrium to act as an inflow to the ecmo circuit.The cannula migrated.As a result, the patient bled out and died.

Manufacturer Narrative

Conclusion: images were submitted to medtronic for review.The patient¿s executive summary was provided for anatomical review.Imaging shows an off axis 4 chamber view.There appears to be very little right and left ventricular heart function, and a possible sievers type i native valve with non-coronary cusp (ncc) and right coronary cusp (rcc) fusion.Evidence suggests that a possible rupture occurred due to the balloon aortic valvuloplasty.Medtronic best practices recommends a pre-dilatation balloon size based on the minor axis of the annulus, and 1mm less than the minor axis for a non-compliant balloon.In this case, the minor axis of the annulus per medtronic measurements was 21.7mm.In this case, a balloon of 25mm as reported exceeded the recommendation.The device history record 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.A medical safety assessment was performed.Based on the information provided, the annular and left ventricular outflow tract (lvot) rupture occurred as a result of the pre-implant balloon aortic valvuloplasty (bav).It is possible that the first valve occluded a coronary artery.After implant of the second valve (non-medtronic) the left main coronary artery was again occluded.Ventricular tachycardia and ventricular fibrillation resulted likely due to the coronary occlusion.Extracorporeal membrane oxygenation (ecmo) was initiated to provide hemodynamic support, but resulted in significant blood loss when the cannula migrated.The death was likely related to the blood loss; however the procedure and device were likely contributors of the death.Other contributing factors include: critical aortic stenosis: mean gradient: 98.4 mm hg: bav done on 1/10/23 decreased gradient to 66 mm hg, ejection fraction of 23%, right ventricle (rv) chamber enlarged, coronary artery disease.Cardiovascular injuries such as rupture are known potential adverse patient effects per the device instructions for use (ifu).These events can be related to the patient's pre-procedural condition and procedural factors, as well as factors related to the device.The rupture was reportedly due to the pre-implant bav.Per the image review, the balloon size exceeded the recommended size.Coronary occlusion is also 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.).Per the medical safety assessment, it is possible that the first valve occluded a coronary artery.Bleeding is a known potential adverse effect per the device ifu and can occur during the implant procedure, with a varying risk that is dependent on several factors such as the access point for the implant, the patient's state of health, and pre-existing medical conditions.The issue is commonly resolved through a blood transfusion or provision of packed red blood cells.Ventricular tachycardia and ventricular fibrillation are types of conduction disturbances.Conduction disturbances are known potential adverse effects per the device ifu.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations.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 transcatheter aortic valve (tav) is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.Per the medical safety assessment, the death was likely related to the blood loss; however the procedure and device were likely contributors of the death.However, with the limited information available, a conclusive root cause could not be determined.This event does not indicate device misuse or malfunction.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.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 FX 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: 16274258
• MDR Text Key: 308503909
• Report Number: 2025587-2023-00360
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: 00763000370701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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 Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/11/2023
• Date Device Manufactured: 10/12/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention; Death
• Patient Age: 65 YR
• Patient Sex: Male