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

Model Number EVOLUTFX-23

Device Problems Difficult or Delayed Positioning (1157); Gradient Increase (1270); Perivalvular Leak (1457); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problems Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Valvular Insufficiency/ Regurgitation (4449)

Event Date 04/15/2024

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the patient had a narrow annulus.As there was a sudden tortuosity in the abdominal aorta, an introducer sheath (18 fr dryseal) was used to extend it prior to introduction of the delivery catheter system (dcs).During the first deployment attempt, the valve dislodged due to the patient¿s high blood pressure and was recaptured.During the second deployment attempt, the valve was at an implant position of 5mm on the non-coronary cusp (ncc) and 3mm on the left coronary cusp (lcc), but the patient developed an atrio-ventricular block (avb), so the valve was recaptured to aim for a shallower spot.At the third deployment attempt, the valve was in good position at 2-3mm on the ncc and 3-4mm on the lcc.The patient¿s hemodynamic status was favorable, with mild paravalvular leak (pvl) and a mean pressure gradient of about 7mmhg.The patient was discharged to the intensive care unit (icu) with continued pacing on a temporary pacemaker, and the atrio-ventricular block (avb) resolved after leaving the operating room.No adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10:  product id l-evolutfx-2329 (lot: 0011858217); 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 dcs; product id: d-evolutfx-2329 (lot: 0011956738); 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.

• 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: 19178942
• MDR Text Key: 341001304
• Report Number: 2025587-2024-02548
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Date Device Manufactured: 04/22/2023
• 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): Hospitalization