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

Model Number EVPROPLUS-29US

Device Problem Fracture (1260)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: d-evprop2329us, serial/lot #: (b)(4), udi#: (b)(4) product analysis: the devices were discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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, a misload was noted due to the out flow strut being bent and broken.The strut had broken inversely and fell into the capsule.A new valve and delivery catheter system (dcs) were used to complete the procedure.The misload was identified during the fluoroscopy check.No adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device history record (dhr) and frame record were reviewed which showed 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.Loading of the valve is a process that is highly dependent on the operator technique.In this case, the inspection process per the i nstructions for use (ifu) was performed and properly identified the bent crowns 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 celcius.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 transcatheter aortic valve 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 delivery catheter system (dcs).As the valve was not returned for analysis, the root cause of the event could not be determined.Updated data: h6 method and conclusion code 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 PRO PLUS 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12533649
• MDR Text Key: 273384522
• Report Number: 2025587-2021-02899
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: EVPROPLUS-29US
• Device Catalogue Number: EVPROPLUS-29US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Date Device Manufactured: 11/17/2020
• 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