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 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id evolutfx-26 (serial: (b)(6)); product type: 0195-heart valves; implant date ; explant date product id evolutfx-26 (serial: (b)(6)); product type: 0195-heart valves; implant date ; explant date product id l-evolutfx-2329 (unknown serial/lot); 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.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 ((b)(6)), a pre-balloon aortic valvuloplasty (bav) was performed with a 22 millimeter (mm) non-medtronic balloon.The valve was deployed at a depth of 2 mm on the non-coronary cusp (ncc) in the cusp overlap view.The valve was deployed and when the delivery catheter system (dcs) was slowly retracted, the nose cone caught onto the outflow and the valve dislodged.A second valve ((b)(6)) was prepped however misloaded at the point of marrying the valve.The first valve was moving into the ascending aorta and a third valve ((b)(6)) was prepared while attempted to fix the first valve in place using a 22 mm then a 25 mm non-medtronic balloon to drag it to the aortic arch.After multiple atte mpts to reposition the valve, it was determined to implant a non-medtronic valve as the dislodged valve continued to descend to the annulus.The third evolutfx was never implanted.The non-medtronic valve was successfully implanted.No additional adverse patient effects were reported.

Event Description

Additional information was received that per the physician, the patient's calcium score was low and contributed to the valve dislodg ement.The second valve misload was identified visually that the valve was folded inside out by the inflow crown.

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.

• 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: 19096385
• MDR Text Key: 340026018
• Report Number: 2025587-2024-02257
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• 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