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

Model Number EVOLUTFX-26

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

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 06/23/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant devices were: product id: d-evolutfx-2329, product id: 23mm true dilatation balloon valvuloplasty catheters (non-medtronic device), product analysis: the valve remains implanted and the dcs was not returned; 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.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was successfully implanted at a target depth of 3mm.The patient¿s mean gradient pre-procedure was approximately 100mmhg and after valve implant it decreased to 9mmhg.The physician noted the valve to be constrained at the annular level.An echocardiogram was performed and identified mild-moderate paravalvular leak.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was performed with a 23mm non-medtronic balloon.During the bav, as the balloon was inflated, the valve dislodged up and out of the annulus.Using a snare, the valve was moved to be clear of the coronary arteries.A second valve was loaded and inserted into the patient; however, the delivery catheter system was unable to pass through the initial valve.The implanting team made the decision to abort the procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated data: b5.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 that the patient¿s annulus may have been a type 1 bicuspid valve; however, the implanting physicians were not sure.The second delivery catheter system (dcs) did not pass the outflow crowns of the initial valve and never reached the intended implant position.It was noted the dcs was not twisted or torqued while in the patient.In addition, there was no patient anatomy that contributed to the dcs unable to pass through the initial valve.No adverse patient effects were reported.

Event Description

Additional information was received that during the implant, a pre-implant balloon aortic valvuloplasty (bav) was performed using an 18mm non-medtronic balloon.Following the bav, the deployment starting point was at the bottom of the pigtail catheter.It was noted the patient was rapid paced during post dilation.Subsequently, after the valve dislodgment, the implant depth was 3mm on the non-coronary cusp and 3mm on the left coronary cusp.A medtronic guidewire was used during the procedure.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the dcs was discarded; therefore, no product analysis can be performed.Updated data: b5.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.

Manufacturer Narrative

Conclusion: the device history record and frame record for the valve were 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 available information, the reported paravalvular leak was related to the valve as the valve was constrained and did not provide adequate seal.The patient¿s anatomy of a type 1 bicuspid valve may have contributed to the valve being constrained.The valve dislodgement was likely caused by the post-implant balloon aortic valvuloplasty (bav) as the dislodgement occurred during inflation of the balloon.All adverse events and severities are documented within the risk files and instructions for use.No further action is required.Without imaging, we are unable to conclusively determine the root cause for the reported expansion issues experienced and if there were any patient anatomy issues that may have prevented the valve from fully expanding.It was reported that the patient may have had a bicuspid valve, which would be a potential contributing factor.A post-implant bav was performed to resolve the under expansion, however the results could not be observed as the valve dislodged.Pvl was reported prior to the post-implant bav.Pvl (inadequate valve seal) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.The pvl was likely a result of the expansion issues.Potential factors that can typically influence a dislodged valve include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, and compliance of the aorta and native vessels.In this event, it was reported that the post-implant bav caused the dislodgement.However, this could not be confirmed 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 reported that the dcs was unable to pass through the initial dislodged valve.This indicates that the probable cause of the advancement difficulties was the dislodged valve, but this cannot be confirmed with the limited information available.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.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: 17292334
• MDR Text Key: 318742466
• Report Number: 2025587-2023-02736
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370695
• UDI-Public: 00763000370695
• 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,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: EVOLUTFX-26
• Device Catalogue Number: EVOLUTFX-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Date Device Manufactured: 11/30/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 75 KG