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)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10:  product id l-evolutfx-2329 (lot: 0012050353); product type: 0195-heart valves; implant date ; explant date 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; explant 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.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 a type 0 bicuspid native valve.Pre-implant balloon aortic valvuloplasty (bav) as performed using an 18mm true balloon over a non-medtronic (lunderquist) guidewire.The valve (b)(6) crossed the annulus and was deployed.Echocardiogram was performed to confirm placement, and the delivery catheter system (dcs) nosecone was attempted to be removed.As the nosecone came through the valve, the valve dislodged.The interventional cardiologist attempted to snare the dislodged valve (b)(6), as a second valve (b)(6) was loaded to attempt implant.However, the patient became unstable prior to attempting second valve implant and cardiopulmonary resuscitation (cpr) was initiated.The second valve (b)(6) was opened but not used, and discarded. the cardiovascular surgeon proceeded to take the patient to the operating room in order to explant the dislodged valve (b)(6) and perform a surgical aortic valve replacement (savr).The surgical valve was successfully implanted.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: 18939447
• MDR Text Key: 338082103
• Report Number: 2025587-2024-01765
• 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,Followup
• Report Date: 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0012084973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/24/2024
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female