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

Model Number EVOLUTFX-29

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923); Central Regurgitation (4068)

Patient Problems Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: d-evolutfx-2329, (lot: 0012076090); product type: 0195-heart valves; product id evolutfx-29 ((b)(6)); product type: 0195-heart valves; implant date (b)(6) 2024; product id edwards sapien; product type: heart valves; implant date (b)(6) 2024; product id: vacs balloon; product type: dilatation balloon.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 implant of this transcatheter bioprosthetic valve, a predilatation was performed with a 22 millimeter (mm) non-medtronic balloon (vacs) after the fluoroscopic valve check.During the valve implant, the physician noticed an infold.The valve and delivery catheter system (dcs) were retrieved from the patient.Another predilatation was  performed with the 22 mm balloon.A new valve was loaded and implanted.The valve dislodged and the implant height on the non-coronary cusp (ncc) was high and aortic insufficiency was observed.Subsequently a second non-medtronic valve (edwards sapien) was implanted valve-in-valve.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.

Event Description

Additional information was received which reported that the infold was first noted on the initial deployment.A procedural delay did not occur as a result of the infold.The replacement valve deployment began at the bottom of the pigtail catheter.Prior to the valve dislodgement, the implant depth was 0-1 mm on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc).Following dislodgement, the valve was out of the ncc cusp and at 0 mm on the lcc.Severe aortic insufficiency occurred as a result.A confida wire was used for this procedure.According to the physician there was nothing of note in terms of patient anatomy that contributed to the dislodgement.

Manufacturer Narrative

Updated data: h6 conclusion: the device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Images were submitted to medtronic for review.The excerpt of the image subject matter expert (sme) review report follows: fluoroscopic cine loops plus fluoroscopic images of the fluoroscopic valve check and implant procedure were provided for review of the event described.Patient summary was not provided for anatomical review.Two images clearly show a crown overlap up to node 4, which constitutes a misload according to medtronic guidelines.Severe calcification is present in the annulus and / or native valve as evidenced by the indents in the pre-implant balloon dilatation in the images.The severely calcified anatomy appears to prevent the bioprosthesis from fully expanding at about 80% deployment.On that provided image, a frame infold is difficult to see.After the alleged valve infold has been identified, a new evolut system is being utilized and the subsequent fluoroscopic valve-check showed an inflow crown overlap up to and around node 3 which is a good load according to medtronic guidance.During the additional pre-implant balloon dilatation, the balloon still showed clear signs of the persisting constriction by severe calcification.It¿s not reported if the image was recorded in 3cusp view or left anterior oblique (lao) projection.However, only left coronary cusp (lcc) implant depth can be assessed here.An image of the initial non-coronary cusp (ncc) depth assessment in cusp overlap view (cov) was not provided.Another image seems to portray a regular implantation in lao view, where in the underlying clip, no movement of the valve frame is recognizable.In cov, the valve appears very constricted and underexpanded.Unfortunately, no cine-loops of the final deployment and actual valve dislodgement were provided.And since also no imagery of the ncc depth assessment in cov was provided, it is impossible to assess how shallow / deep the valve was eventually placed.The degree of annulus / cusp calcification or the type of valve (bicuspid / tricuspid) was not described.However, it becomes clear from the different pre implant balloon dilatations that there was a persisting severe calcification present in the annulus / native valve leaflets.This calcification led or contributed to the severe underexpansion seen in the right anterior oblique (rao) /cau (cov) projections.If indeed a bicuspid native anatomy was present but not reported, this could have added to the effect of valve underexpansion.It¿s safe to say that the patient¿s constricting anatomy has played a major role in the dislodgement of the valve.The medical safety assessment was performed.The excerpt of the subject matter expert (sme) review report follows: based on the information provided, the primary event of valve dislodgement, resulting in severe aortic insufficiency and implant of a 2nd (non-mdt) transcather valve, was likely related to the evolut fx valve that was underexpanded after deployment likely due to the patient's contricting anatomy due to severe aortic calcification.The reported adverse events and severities are documented in the risk management files and instructions for use.No further safety assessment is required at this time.Per medtronic best practices, the target depth of implantation is 3 millimeter (mm).Recapture is recommended if depth :1mm or >5mm.Furthermore, depth assessment at the ncc is performed in a cusp overlap view, and if acceptable, next step is to move to the 3-cusp coplanar view and remove parallax from the inflow portion of the valve (roll lao no greater than 25°) to verify depth at the lcc.The valve may be released once these steps are completed.In this case, prior to the valve dislodgement, the implant depth was 0-1 mm on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc) so a recapture was warranted.However, the valve was released and dislodged.Potential factors that can influence a dislodged valve include tension applied on the dcs during positioning, calcification levels in the native vessel, compliance of the aorta and native vessels, and a number of others.However, the patients heavily calcified and bicuspid native anatomy contributed to the valve dislodgement.Per the device instructions for use (ifu), in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant ball oon dilation of the bioprosthesis may improve valve function and sealing.No post implant balloon dilation was reported in this case.Aortic regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-exist ing patient conditions.In this case the regurgitation was due to the valve dislodgement.This event does not indicate device misuse or malfunction.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.

• 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: 18843096
• MDR Text Key: 336958961
• Report Number: 2025587-2024-01402
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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: 03/06/2024
• Date Device Manufactured: 12/02/2023
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Required Intervention