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

Model Number EVOLUTR-26

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/11/2024

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the patient presented with severe aortic stenosis, bicuspid type 0 valve with severe calcification, and a pressure gradient of 108 millimeters of mercury (mmhg).A pre-implant dilation was performed with an 18 millimeter (mm) balloon.The valve was implanted under pacing rate of 180 beats per minute (bpm) at a depth of 1 mm on the non-coronary cusp (ncc) and 3 mm on the left coronary cusp (lcc).There was a plant to post dilate the valve with a 20 mm balloon, but after fully deployment of the valve, the valve gradually dislodged aortic without movement of the nose cone of the delivery catheter system (dcs).The left ventricular outflow tract (lvot) gradient was effected and a systolic blood pressure of 180 mmhg was reported.The valve was snared into the ascending aorta and a new valve was loaded.The native valve was pre-dilated again with an 18 mm balloon.The second valve was fully deployed under pacing at an implant depth of 5 mm on the ncc and 6 mm on the lcc.The valve was post dilated with a 20 mm balloon two times.The final angiogram showed trace paravalvular leak (pvl) with a gradient of 6 mmhg.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.

Manufacturer Narrative

Updated data: a3b b5 continuation of d10: product id: evolutr-26; product lot/serial number (b)(6); product type: heart valve; implant date: (b)(6) 2024; product id: envpro-14; product lot/serial number (b)(6); product type: delivery catheter system; this regulatory report is associated to regulatory report 2025587-2024-02356.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 the post implant balloon aortic valvuloplasty (bav) was performed due to expansion issues and the patient was rapid paced during the bav.

• 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: 19123053
• MDR Text Key: 340337218
• Report Number: 2025587-2024-02308
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-26
• Device Catalogue Number: EVOLUTR-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Date Device Manufactured: 05/28/2023
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG