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

Model Number EVOLUTR-29

Device Problems Failure to Align (2522); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

The device remains implanted, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, while the valve was initially being fully released, it was tilted shallowly.A post balloon aortic valvuloplasty (bav) was performed with an 18 mm balloon and the valve anchoring was completely misaligned.The distance between the valve and the annulus was approximately 1 cm.Subsequently, a second transcatheter bioprosthetic valve was successfully implanted valve in valve.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7716138
• MDR Text Key: 114895449
• Report Number: 2025587-2018-01849
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: 02/02/2020
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 02/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 42