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

Model Number EVOLUTR-34

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2024

Event Type  Injury  

Manufacturer Narrative

Initial reporter details unavailable due regional privacy regulations.Select patient information cannot be included in the regulatory report due to regional privacy regulations.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, the valve was positioned correct and confirmed during the angiographic check.The valve was released and dislodged ventricular.The patient was sent to cardio surgery and the valve was explanted.No additional adverse patient effects were reported.

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.

Event Description

Additional information was received that a pre-balloon aortic valvuloplasty (bav) was performed.After the valve was explanted, a su rgical valve was implanted.

Manufacturer Narrative

Image review: four static images were provided for review of the event.The patient¿s executive summary was not provided for anatomical review.It appears that the cusp overlap technique was used, however, depth assessment in the cusp overlap view was not provided for review.Just prior to the point of no recapture, depth assessment was performed in the left anterior oblique (lao) view and appeared to be approximately 8-9mm at the left-coronary cusp (lcc).In this case, proper depth assessment at the non-coronary cusp (ncc) was not confirmed, so depth at the ncc is unknown.Medtronic recommends a target depth of 3mm.Recapture is recommended if depth <(><<)>1mm or >5mm.Thus, a recapture was warranted.However, the valve was released and dislodged ventricular.It was reported that the patient was converted to surgery to explant the dislodged valve.Updated: d9, h3, h6 note: the returned device has been received, however, product analysis had not yet been completed.Results of the product analysis will be submitted upon analysis completion.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 R TRANSCATHETER AORTIC 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: 19161191
• MDR Text Key: 340794720
• Report Number: 2025587-2024-02464
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 05/29/2024

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 Expiration Date: 05/07/2024
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024; Not provided
• Supplement Dates FDA Received: 04/25/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2023
• 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 Sex: Male