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

Model Number EVOLUTFX-29

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Heart Block (4444)

Event Date 04/01/2024

Event Type  Injury  

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve in a patient with a bicuspid aortic valve and a horizontal aorta, a pre-implant balloon aortic valvuloplasty was performed.The valve and delivery catheter system (dcs) were inserted into the patient and the valve was deployed following several attempts to advance the dcs to an appropriate depth.Following deployment, the valve dislodged to a depth of 12 mm on the non-coronary cusp and 12 mm on the left coronary cusp.Subsequently, the patient developed complete heart block, and a permanent pacemaker was implanted two days following the valve implant.It was also reported that the patient developed atrial fibrillation and right arm and hand weakness.A stroke was suspected, but unable to be confirmed via magnetic resonance imaging due to the permanent pacemaker implant.No additional adverse patient effects were reported.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: product id: d-evolutfx-2329; lot #: 0012103480; ubd: 2026-01-08; udi#: (b)(4), product id: l-evolutfx-2329; lot #: unknown; ubd: unknown; udi#: unknown.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.

Manufacturer Narrative

Updated data: a3b b5 section d references the main component of the system.Other medical products in use during the event include: product id: safari; product type: guidewire.Additional codes 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

Additional information was received that during the valve implant, the deployment starting point was at the bottom of the pigtail at an implant depth of 8 millimeter (mm) on the non-coronary cusp (ncc) and 2 mm on the left coronary cusp (lcc).A non-medtronic guidewire (safari) was used during the implant.New atrial fibrillation (afib) was also reported during the valve implant.Anticoagulation medication was provided for afib.Approximately 36-48 hours after the valve implant, the stroke symptoms were observed and not treatment was reported.The stroke resolved approximately 7-10 days later.The cause of the stroke was unknown.No additional adverse patient effects were reported.

• 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: 19105284
• MDR Text Key: 340152528
• Report Number: 2025587-2024-02272
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: 00763000370701
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/26/2024
• Date Device Manufactured: 01/29/2024
• 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; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 67 KG