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 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.

Event Description

Medtronic received information that during the loading of this transcatheter bioprosthetic valve, the loader tried to crimp the valve.No issues were observed during loading up to the beginning of the commissures.At that point, the valve began to bend.It was reported that it was very difficult to close the valve inside the capsule.The loader decided to re-open the valve.As the valve was opened, the loader noticed a fracture in the valve frame.The valve was exchanged for a new valve and the delivery catheter system (dcs) was replaced.The procedure was completed successfully using the replacement system.Of note, it was reported that the loader was experienced.No adverse patient effects were reported.

Manufacturer Narrative

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.Unfortunately, the valve has not been returned for analysis to date.However, it should be known that 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 area of the valve during loading, prior to introduction to the patient.And then, when the loader re-opened / expanded the valve, it was noted that there was a stent break or fracture.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 transcatheter aortic 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), which most likely occurred in this event.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.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.

Manufacturer Narrative

Conclusion: it should be known, that 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 to identified the bent area of the valve during loading, prior to introduction to the patient.And then, when the loader re opened / expanded the valve, it was noted that there was a stent break or fracture.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 tav¿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 cls or the dcs, which most likely occurred in this event.In addition, based on observations and event description, valve f138085 experienced breakage of a frame strut, which is consistent with overloading while loading the valve into the delivery system and ultimately triggers a fracture.The concluded root caused is a misload.This event does not indicate device misuse or malfunction.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was returned via fedex inside its original jab submerged in clear solution.All leaflets were flexible and intact.All leaflets were in the closed position.All commissures were intact.Visual inspection revealed a frame fracture between cells c124 and c133 in addition to multiple kinked struts lateral to the c paddle.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 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: 15754725
• MDR Text Key: 304788349
• Report Number: 2025587-2022-03123
• 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,Followup,Followup,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2023
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male