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

Model Number EVOLUTR-23

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, all leaflets of the valve were flexible and intact.The leaflets were slightly twisted, in the closed position with gaps between the free margins of l1 and l3 as well as between l2 and l3.All commissures were intact.Bends were observed on the multiple cells of the frame.The frame of one paddle was broken.Conclusion: the device history record for (b)(4) and associated frame lot was reviewed and showed that this device met all manufacturing specifications for final product released for distribution.No issues were identified that would have impacted this event.Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique; the evolut inst ructions for use (ifu), contains instructions to use the integrated loading bath which features a mirror to aid in loading of the valve.The user is instructed to not advance the capsule over the frame paddles unless they are fully seated in the center of the paddle pockets in order to avoid damage to the capsule and to avoid emboli.The damage is suggestive of possible frame misalignment during loading.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the valve was loaded onto the de livery catheter system (dcs) and appeared to be sheathed properly until a loud, audible "snap" was heard as the last third of the valve was sheathed.The end of the dcs was discolored and when the valve was unsheathed, a paddle on the valve frame had completely snapped off.A new valve was loaded onto a new dcs and successfully implanted.No adverse patient effects were reported.

• 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: 10705039
• MDR Text Key: 212109443
• Report Number: 2025587-2020-03164
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Date Device Manufactured: 10/08/2019
• 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