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)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/27/2024

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient had calcified anatomy for which a pre-implant balloon aortic valvuloplasty (bav) was not performed.Per the medtronic sales representative, in hindsight a pre-implant bav should have been performed.When the valve was at 80% deployment, the implant depth was around 3mm on the non-coronary cusp (ncc) and 4mm on the left coronary cusp (lcc).Some constraint was noted on the ncc side.The valve was deployed successfully, however dislodged up to -2mm on the ncc and 2mm on the lcc after deployment.Echocardiogram and radiographic cine showed moderate-severe paravalvular leak (pvl), therefore a post-implant bav was performed.Foreshortening occurred and the valve was at around -5 to -6mm on the ncc side.The team decided to treat the patient with a second valve.A new valve and delivery catheter system (dcs) were inserted into the aorta and positioned through the first valve, down to the annulus.At that point, visualization of the cusp was poor.The implanted valve had further dislodged, and the skirt was in front of the coronary arteries.Decision was made to abort the second evolut fx, to snare the dislodged valve and implant a non-medtronic (edwards sapien) valve in the aortic annulus.The second evolut fx and the dcs were removed from the patient.The dislodged valve was ballooned and snared up above the coronary arteries, but still in the ascending aorta.The sapien valve was then deployed successfully in the aortic annulus.A procedural delay occurred as a result of the dislodgement, with total procedural time of around 3 hours.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: product id: l-evolutfx-2329, product type: compression loading system (cls).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.

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 after the post-implant bav was performed, severe pvl occurred.No additional adverse patient effects were reported.

Event Description

Additional information was received that during advancement of the second dcs, the dcs contributed to the valve dislodging further when attempting to implant the second medtronic transcatheter valve.No additional adverse patient effects were reported.

Manufacturer Narrative

This is a system report.The section d information is for the primary device, which was in use with the following: brand name [deliv sys d-evolutfx-2329] product id [d-evolutfx-2] serial/lot [(b)(6)] use by date [2026-01-02] 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.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient had calcified anatomy for which a pre-implant balloon aortic valvuloplasty (bav) was not performed.Per the medtronic sales representative, in hindsight a pre-implant bav should have been performed.When the valve was at 80% deployment, the implant depth was around 3mm on the non-coronary cusp (ncc) and 4mm on the left coronary cusp (lcc).Some constraint was noted on the ncc side.The valve was deployed successfully, however dislodged up to -2mm on the ncc and 2mm on the lcc after deployment.Echocardiogram and radiographic cine showed moderate-severe paravalvular leak (pvl), therefore a post-implant bav was performed.Foreshortening occurred and the valve was at around -5 to -6mm on the ncc side.The team decided to treat the patient with a second valve.A new valve and delivery catheter system (dcs) were inserted into the aorta and positioned through the first valve, down to the annulus.At that point, visualization of the cusp was poor.The implanted valve had further dislodged, and the skirt was in front of the coronary arteries.Decision was made to abort the second evolut fx, to snare the dislodged valve and implant a non-medtronic (edwards sapien) valve in the aortic annulus.The second evolut fx and the dcs were removed from the patient.The dislodged valve was ballooned and snared up above the coronary arteries, but still in the ascending aorta.The sapien valve was then deployed successfully in the aortic annulus.A procedural delay occurred as a result of the dislodgement, with total procedural time of around 3 hours.No additional adverse patient effects were reported.Additional information was received that after the post-implant bav was performed, severe pvl occurred.No additional adverse patient effects were reported.Additional information was received that during advancement of the second dcs, the dcs contributed to the valve dislodging further when attempting to implant the second medtronic transcatheter valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated data: h6.Eval code method updated for the delivery catheter system.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.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: 19059073
• MDR Text Key: 339584227
• Report Number: 2025587-2024-02146
• 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,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• 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: 04/15/2024
• Date Device Manufactured: 07/03/2023
• 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: 87 YR
• Patient Sex: Female
• Patient Weight: 57 KG