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

Model Number EVOLUTFX-29

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed with a 22 millimeter (mm) non-medtronic balloon due to patient's bicuspid aortic valve.The 14 french (fr) sheath was removed and the delivery catheter system (dcs) was advanced.The valve was deployed to 80% and was  very shallow and moved aortic.The valve was recaptured and re-deployed.The valve appeared very constrained and was determined to recaptured and removed from the body and bav with a 23 mm balloon.A new valve was loaded with a new dcs and successfully deployed.At the time of the procedure, the patient complained of neck pain.Post implant computed tomography (ct) revealed an aortic dissection.The patient was taken to the operating room to repair the dissection.The valve was explanted and a non-medtronic surgical valve was placed.Following the procedure, the patient was reported to be doing well.Per the physician, the patient's bicuspid valve contributed to the event.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: product id: d-evolutfx-2329 (unknown serial/lot); product type: 0195-heart valves.Section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx valve; product id evolutfx-29 (unknown serial/lot); product type: 0195-heart valves.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 procedure delay of approximately 10 minutes occurred due to the valve being constrained.Per the physician, the patient's bicuspid valve contributed to the valve being constrained.Per the physician, it is unknown what caused the trauma at the sinotubular junction (stj) level.

Manufacturer Narrative

This is a system report.The section information is for the primary device, which was in use with the following: brand name deliv sys d-evolutfx-2329 product id (b)(4) serial/lot (b)(6) use by date 2025-05-14 udi (b)(4).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: 19077240
• MDR Text Key: 339775514
• Report Number: 2025587-2024-02197
• 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: 04/24/2024

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: 03/28/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/13/2024; 04/13/2024
• Supplement Dates FDA Received: 04/24/2024; 04/24/2024
• Date Device Manufactured: 12/20/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 83 KG