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

Model Number D-EVOLUTFX-2329

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

Patient Problem Vascular Dissection (3160)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: evolutfx-26, serial/lot #: (b)(6), ubd: 26-feb-2025, udi#: (b)(4) one media file and a mpxr questionnaire were provided for review.As stated in the event description, the depth prior to valve release was 1mm.As stated in the instructions for use (ifu), the recommended target depth is 3 millimeter (mm) relative to the valve annulus.If the implant depth is =1 mm or >5 mm, consider recapture.Caution: bioprosthesis implant depth =1 mm may contribute to an increased risk of prosthetic valve dislodgement during valve release, delivery catheter system (dcs)retrieval, or post-implant dilatation.Bioprosthesis implant depth >5 mm may contribute to an increased risk of conduction disturbances, which may require a permanent pacemaker.In this case, the depth was 1mm which warranted a recapture.However, the valve was deployed in the native annulus, and while withdrawing of the delivery catheter system, the nose cone interacted with the valve which resulted in aortic dislodgement.Fluoroscopic image of the nose cone interaction was not saved for review.Medtronic recommends caution while withdrawing the delivery catheter system to minimize interaction with the evolut frame.The dislodged valve appeared to be moving freely in the ascending aorta and an aortic dissection is evident.It was reported that attempts were made to move the valve which may have contributed to the dissection.Of note, as stated in the ifu, physicians should use judgment when considering repositioning a fully deployed bioprosthesis (for example, using a snare, balloon, and/or forceps).Repositioning the bioprosthesis is not recommended, except in cases where imminent serious harm or death is possible (for example, coronary occlusion).Repositioning of a deployed valve may cause aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery.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 bicuspid anatomy with a fused r and l commissures and aneurysmal ascending aorta, a pre-balloon aortic valvuloplasty (bav) was performed with a semi compliant balloon.The valve was deployed and released at a depth of 1 millimeter (mm).Upon retrieval of the nose cone, the valve dislodged into the ascending aorta.The valve was attempted to be snared and pulled distally from the major vessels.A bare metal stent was attempted to be deployed through the valve to anchor it to the aorta as it was moving freely in the aneurysmal anatomy.A controlled dissection was then noted on the outer curvature of the ascending aorta.The procedure was converted to surgical repair which was successful and the valve was removed and replaced with a new valve.Per the physician, it is unknown if the non-medtronic guidewire, the dcs, or the valve when it dislodged caused the dissection.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated h.6 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 DCS
• 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: 19090690
• MDR Text Key: 339985714
• Report Number: 2025587-2024-02237
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0011651366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• Date Device Manufactured: 02/23/2023
• 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