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

Model Number D-EVOLUTFX-2329

Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Non specific EKG/ECG Changes (1817); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: evolutfx-29, serial #: (b)(6), ubd: 21-sep-2025, udi#: (b)(4).Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.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, standard for implanting physician.Following the bav, slow deployment of the valve was observed, and the valve was implant in the native annulus.While withdrawing the delivery catheter system from the patient, the valve dislodged due to nose cone interaction.Premature withdrawal of the catheter was reported.Subsequently, a second valve was implanted successfully.Per the physician, the nose cone caused the dislodgement.The physician reported to pulled wire back to the center, but advanced wire back prematurely to not loose access across the aortic valve.A medtronic confida guidewire was used during the procedure.It was noted that the patient was not harmed throughout the procedure.No procedural delay occurred as a result of the issue.No additional adverse patient effects were reported.

Manufacturer Narrative

Corrected data: a3b.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.

Manufacturer Narrative

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 a medtronic guidewire was used during the procedure.The training guidance for slow deployment of the valve was followed.Prior to slowly with drawing the delivery catheter system (dcs), the nosecone was centered within the frame inflow by slightly retracting the guidewire.The dcs was not twisted or torqued at any point during deployment.Per the physician, an ectopic beat caused the nose cone of the dcs to move and caught the bottom of the valve.Additionally, patient anatomy was not a contributing factor to the dislodge.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated data: b5 - event description h6 - method code.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 during the valve implant, the right femoral artery was used for access.Cuspal overlap technique was used during implant.As the physician was retrieving the delivery catheter system (dcs) through the valve and was almost out, the physician pushed the guidewire back through.The nosecone of the dcs caught onto the bottom of the valve when the physician advanced the guidewire causing the valve to dislodge.

Manufacturer Narrative

Updated h.6 images were submitted to medtronic for review.The excerpt of the image subject matter expert (sme) review report follows: one static image was provided for review of the event description above.Patient¿s executive summary was not provided for anatomical review.It was reported that the valve was deployed in the native annulus, and while withdrawing of the delivery catheter system, the nose cone interacted with the valve which resulted in aortic dislodgement.Subsequently, a second valve was implanted within the dislodged valve.Fluoroscopic image of the nose cone interaction was not saved for review.Medtronic recommends caution while withdrawing the delivery catheter system to minimize interaction with the evolut frame.Of note, as stated in the instructions for use (ifu), prosthetic valve migration/embolization is listed as a potential risk associated with the implantation of the evolut fx bioprosthesis.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 DCS
• 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: 18885317
• MDR Text Key: 337427881
• Report Number: 2025587-2024-01543
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0011956743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Date Device Manufactured: 09/16/2023
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female