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); Device Dislodged or Dislocated (2923); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problems Obstruction/Occlusion (2422); Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/18/2024

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id d-evolutfx-2329 product lot/serial number unknown.Product type: delivery catheter system (dcs) implant date implant date na explant date na product id l-evolutfx-2329 product lot/serial number unknown product type: compression loading system (cls) implant date na explant date na product id 22 mm true balloon; product lot/serial number unknown; product type: valvuloplasty balloon.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 , the valve was implanted at a depth of 3 millimeter (mm) on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc).Mild paravalvular leak (pvl) with constrainment was noted on an echocardiogram and angiogram post deployment.A post balloon aortic valvuloplasty (bav) was performed with a 22 mm non-medtronic balloon.The balloon was being pulled out of the valve before it was completely deflated which results in the valve being pulled with it.The valve dislodged into the sinuses.The patient was stable and the coronary arteries were perfusing.  as materials were being grabbed to snare the valve, the valve shifted and occluded the left main artery.The patient decompensated.It was attempted to snare the valve up and it was determined to put in extracorporeal membrane oxygenation (ecmo).The valve was surgically explanted and a surgical valve was implanted.The ejection fraction (ef) went down to 5-10%.The patient continued to decline and did not come off bypass post surgery.The patient subsequently died.

• 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: 18980063
• MDR Text Key: 338619728
• Report Number: 2025587-2024-01908
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 03/18/2024
• Date Device Manufactured: 01/10/2024
• 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; Death
• Patient Age: 69 YR
• Patient Sex: Female