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

Model Number D-EVOLUTFX-2329

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id l-evolutfx-2329 (lot: 0012056288); product type: 0195-heart valves section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx valve; product id evolutfx-26 (serial: (b)(6)); product type: 0195-heart valves; implant date (b)(6) 2024.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 device was inspected prior to use and no pre-implant balloon aortic valvuloplasty (bav) was performed.The patient had a septal bulge.A safari guidewire was used to attempt implant of the the valve into the patient's native annulus.At 80% deployment, the valve was at an implant depth of 3mm.At 100% deployment, the valve was at an implant depth of 0 to -1mm. the delivery catheter system (dcs) was not twisted or torqued during deployment, and training guidance for slow deployment of the valve was followed.Prior to withdrawing the dcs, the nose cone was centered within the frame inflow by slightly retracting the guidewire.  while removing the dcs, the nose cone contacted the outflow of the valve and caused the valve to dislodge.Prior to dislodgment, the implant depth was 0mm on the non-coronary cusp (ncc) and 2mm on the left coronary cusp (lcc).After dislodgement, the valve's position was in the ascending aorta and sinotubular junction (stj).The valve was snared and a non-medtronic valve (sapien 3 ultra resilia) was implanted.No pre-implant or post-implant balloon aortic valvuloplasty (bav) was performed during the procedure.No procedural delay occurred.No additional adverse patient effects were reported.

• 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: 19151847
• MDR Text Key: 340691464
• Report Number: 2025587-2024-02410
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: 00763000365677
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: 0012084971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Date Device Manufactured: 12/19/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 103 KG