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); Device Dislodged or Dislocated (2923); Central Regurgitation (4068)

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

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: d-evolutfx-2329, product type: delivery catheter system (dcs).  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

Medtronic received information that during implant of this transcatheter bioprosthetic valve into a patient with a heavily calcified native bicuspid valve with horizontal angulation (approx 65 degrees) and a short ascending aorta, a pre implant balloon aortic valvuloplasty (bav) was performed using a 24 mm non-medtronic true balloon.The physician had difficulties placing the pigtail catheter due to a "heavy jet".The physician also reported difficulties positioning the delivery catheter system (dcs).The physician attempted to deploy the valve after several attempts to place the dcs inside the annulus.The valve was recaptured once. after deploying the valve again to the point of no recapture, the valve remained stable and the physician decided to fully release the valve.After removing the nosecone of the dcs into the descending aorta, the valve dislocated from the non coronary cusp (ncc).The patient remained stable during the procedure.Moderate aortic regurgitation and a diastole pressure of around 45mmhg were reported.The dislodged valve was then snared using two snare catheters into the ascending aorta.A second evolut valve, dcs and compression loading system (cls) were used.The replacement valve was implanted successfully inside the annulus.The procedure ended with good hemodynamics according to the physician.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated b5.Updated h6.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 which reported that the moderate ar was classified as paravalvular leak (pvl).The deployment starting point was the bottom of the pigtail catheter.The direction of the dislodgement was aortic.The implant depth after the dislodgement on the non-coronary cusp (ncc) could not be judged accurately according to the physician, but it was several mm above the annulus.The implant depth on the left coronary cusp (lcc) was around 1mm.There are no information available regarding the wire used in this case.

• 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: 18942702
• MDR Text Key: 338148113
• Report Number: 2025587-2024-01786
• 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: 04/02/2024

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?: Yes
• 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: 03/18/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/02/2024
• 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