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

Model Number EVOLUTFX-34

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

Patient Problems Sepsis (2067); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient had tortuous anatomy.The patient had a horizontal root of 60 degrees with an acute bend of the aorta at level of sinotubular junction (stj), toward left shoulder.The valve ((b)(6)) was successfully implanted and a post-implant balloon aortic valvuloplasty (bav) was performed due to paravalvular leak (pvl), using rapid pacing.While attempting to remove the balloon from the valve, the tip of the balloon caught on the valve and caused the valve to dislodge.Prior to valve dislodgement, the implant depth on both the non-coronary cusp (ncc) and left coronary cusp (lcc) was 3mm.After valve dislodgement, the valve was repositioned to the aorta/stj.A second valve ((b)(6)) was implanted successfully.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10:  product id d-evolutfx-34 (lot: 0011630247); product type: 0195-heart valves; implant date ; explant date product id evolutfx-34 (serial: (b)(6)); 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

Updated data: b2.Outcome attributed added b5.Second paragraph added h6.Patient and device codes added additional codes added 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 the implant of this transcatheter bioprosthetic valve, the patient had tortuous anatomy.The patient had a horizontal root of 60 degrees with an acute bend of the aorta at level of sinotubular junction (stj), toward leftshoulder.The valve was successfully implanted and a post-implant balloon aortic valvuloplasty was performed due to paravalvular leak, using rapid pacing.While attempting to remove the balloon from the valve, the tip of the balloon caught on the valve and caused the valve to dislodge.Prior to valve dislodgement, the implant depth on both the non-coronary cusp and left coronary cusp was 3mm.After valve dislodgement, the valve was repositioned to the aorta/stj.A second valve was implanted successfully.No additional adverse patient effects were reported.Additional information was received that three days following valve implant, the patient returned to the hospital with sepsis and st roke-like symptoms.A computed tomography scan of the head and chest was performed and revealed no stroke, but a possible dissection of the aortic root.The patient recovered from symptoms and was discharged home without intervention performed for the dissection.No additional adverse patient effects were reported.

• 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: 18994442
• MDR Text Key: 338887251
• Report Number: 2025587-2024-01955
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370718
• UDI-Public: 00763000370718
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-34
• Device Catalogue Number: EVOLUTFX-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Date Device Manufactured: 03/19/2023
• 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; Life Threatening
• Patient Age: 89 YR
• Patient Sex: Male