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

Model Number EVOLUTFX-29

Device Problems Perivalvular Leak (1457); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Vascular Dissection (3160); Valvular Insufficiency/ Regurgitation (4449)

Event Date 04/26/2023

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the valve was implanted and then a post- balloon aortic valvuloplasty (bav) was performed.During the post-bav, rapid pacing was paused and then the valve dislodged into the aorta.A second valve was prepared and inserted into the body.The first valve was snared, however, the second valve could not advance through the first valve.A second snare was attempted and placed on the inflow of the first valve.Again, the second valve was unable to advance through the first valve.An angiogram was taken, and a dissection was observed.A transesophageal echocardiogram (tee) was performed to confirm the dissection.The procedure was converted to open aortic valve replacement (avr) and possible repair for the dissection.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: d -evolutfx-2329, serial/lot #: (b)(6), ubd: 23-jan-2025, udi#: (b)(4).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.

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 indicating that pre-implant balloon aortic valvuloplasty (bav) was not performed.A medtronic (confida) guidewire was used during the procedure.Deployment was started at the bottom of the pigtail catheter.Prior to dislodgement, the valve was positioned at 5 millimeter (mm) on the non-coronary cusp (ncc) and 7mm on the left coronary cusp (lcc).It was reported that the post-implant bav was performed due to mild-moderate paravalvular leak (pvl).Following dislodgement, the valve was positioned at a depth of approximately -5mm.It was reported that the dissection occurred in the sinotubular junction/ascending aorta during attempted advancement of the second delivery catheter system (dcs).It was reported that the dislodged valve caused or contributed to the dissection.It was confirmed that the valve was explanted and a surgical valve was implanted, and surgical repair of the dissection was performed.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: two media files were provided for review of the event.The patient¿s executive summary was provided for anatomical review.The patient¿s annulus perimeter was 76.8 millimeter (mm) with a perimeter derived diameter of 24.5mm, suggesting a 29mm evolut.Per the event description, the valve dislodged due to the post-implant balloon aortic valvuloplasty (bav).Per the device instructions for use (ifu) ¿prosthetic valve migration/embolization is listed as a potential adverse reaction.Per the device ifu: ¿physicians should use judgment when considering repositioning a fully deployed bioprosthesis (for example, using a snare, balloon, and/or forceps).Repositioning the bioprosthesis is not recommended, except in cases where imminent serious harm or death is possible (for example, coronary occlusion).Repositioning of a deployed valve may cause aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery.¿ the valve was snared into the ascending aorta, and an aortogram was performed confirming a dissection at the level of the sinuses of valvalsa and sinotubular junction.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.Medical safety reviewed the event.Based on the information provided, the primary event of mild to moderate paravalvular leak (pvl) was due to the valve as there was not an adequate seal.The reported adverse events and severities are documented in the risk management files and ifu.No further safety assessment is required at this time.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.Dislodge events are typically not related to a device malfunction.In this case, the bav caused the valve to dislodge.This is a use-related issue.Pvl is a known potential adverse effect per the device 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 cause could not be determined from the information available.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the second valve was unable to be advanced through the first, dislodged valve.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Vascular complications, such as dissection, are a known potential adverse effect per 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.With the limited information made available, a definitive root cause cannot be determined.The dislodgement, snaring, and second valve implantation attempt may have been contributing factors.This event does not indicate device 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: 16881836
• MDR Text Key: 314710376
• Report Number: 2025587-2023-01958
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• 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
• Date Manufacturer Received: 07/12/2023
• Date Device Manufactured: 10/21/2022
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 92 KG