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

Model Number EVOLUTR-34

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the valve was received in its original container jar without any solution.Leaflets one and two were in the closed position while leaflet three was opened towards the frame wall.All leaflets were flexible and intact.All commissures appeared intact.Two fractures were observed between the cell nodes.Adjacent deformations were noted between the cell nodes.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Analysis of the returned valve confirmed the report.The valve as received has two fractured struts between c125/c124 and c17/c18, with adjacent bent deformed cell nodes.Loading of the valve is a process that is highly dependent on the operator technique; in this case, the inspection process per evolutr ifu was performed and properly identified the damaged and bent struts on the valve, prior to introduction to the patient.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/ damage 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 damage or deformation of the nitinol frame can result from subjecting the device to extreme deformation conditions, such as those occurring during severe misloads of the valve into the cls or the dcs.This event took place prior to introduction of the patient, and no adverse patient effects were reported.This event does not indicate device misuse or malfunction.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 34mm transcatheter bioprosthetic valve, using a 16 french compression loading system (cls), during the crimping process, the experienced loader noticed two struts in the valve frame were broken.A new 34mm valve was used without further issues during the load.No adverse patient effects were reported.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 8692046
• MDR Text Key: 147768419
• Report Number: 2025587-2019-01904
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2019
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR