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

Model Number EVOLUTR-29

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the valve was loaded by an experienced and certified hospital nurse in the presence of the certified sales agent.When the valve was inserted into the compression loading system, the nurse noted that one of the ¿crowns¿ on the outflow portion of the valve frame, next to the paddle, was bent.Attempts to straighten the crown by moving the valve in room temperature saline were unsuccessful.A surgical clamp was also used; however, it was not possible to straighten the outflow crown.The valve was not used.A new valve and a new loading system were used for the procedure.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received in its original packaging and original solution submerged in clear solution.The serial number tag (b)(4) was received with the valve.All leaflets were pliable and intact.Leaflets 1 (l1) and 2 (l2) were in the closed position while leaflet 3 (l3) was partially open.All commissures were intact.One broken strut was observed on the strut adjacent to paddle 1 (cell c81) with bends noted adjacent to the break.The damage on the frame is suggestive of frame misalignment during the loading process.Conclusion: analysis of the returned valve found multiple bends on the strut adjacent to paddle 1.In addition, one of the struts was broken.This type of damage suggests that there was frame misalignment during the loading process that led to this type of damage to the valve frame.Loading of the valve is a process that is highly dependent on the operator technique.In this case, the inspection process per the instructions for use (ifu) was performed and properly identified the bent crowns on the valve, prior to introduction to the patient.There was no mention in the event description of a strut fracture, however, it was reported that the user used a surgical clamp, so it¿s unknown if the user was trying to bend the frame and the frame fractured.It should also be noted that per the medtronic best practices training, the temperature of the loading bath should be between 0-8 degrees celsius.Bath temperatures not sufficiently chilled can lead to excess loading forces.In addition, proper lighting should always be used to visually confirm paddles are properly seated and all outflow crowns are captured within the capsule.While nitinol is a material which features ¿shape memory¿ and ¿super-elastic¿ material properties, extreme levels of strain/deformation beyond the elastic properties of the materials result in permanent/plastic deformation which is not reversed by warming the material.This effect is amplified if the loading process / deformation is not performed while the material is at sufficiently low temperatures, i.E.Ice bath conditions.Permanent deformation of the valve¿s nitinol frame can result from subjecting the device to extreme deformation conditions, such as those occurring during severe misloads of the valve into the compression loading system (cls) or the delivery catheter system (dcs).This event took place prior to introduction of the patient, and no adverse patient effects were reported.Review of the device history record and frame record for this device found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.This event does not indicate device misuse or malfunction.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 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: 14161624
• MDR Text Key: 292582957
• Report Number: 2025587-2022-01029
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1