MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number ENVPRO-14

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921); Positioning Problem (3009)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve using this delivery catheter system (dcs), during the recapture, the pigtail catheter became stuck between the valve and the capsule of the dcs.This resulted in blockage of the valve recapture.The capsule became compressed and buckled.The valve was not able to be completely recaptured.The valve and dcs were carefully retracted.There was no reported injury within the femoral artery.A replacement valve was loaded onto a replacement dcs.The procedure was then able to be completed successfully.No adverse patient effects were reported.

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.

Manufacturer Narrative

Updated data: b5 - additional information was received that prior to loading the valve, no misload was identified.No unusual resistance felt or loading difficulties were noted.The valve compression was noted after the second recapture.Of note, while using the computed tomography (ct) view, the implanters were unable to view the upper part of the catheter and only the capsule.The valve compression may have been present after the first recapture.The valve was recaptured due to shallow height.The valve was withdrawn from the patient by recapturing the valve as much as possible and then released the tension slowly to straighten the catheter.The dcs was then slowly and carefully retracted from the patient.Due to a larger access hole, an 18 french(fr) introducer sheath was used with the new valve and dcs and no bleeding was observed.No additional adverse patient effects were reported.H6 - device 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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received with the capsule partially opened and the nosecone exiting the capsule tip at an angle.The handle was intact and the end cap/screw gear snap fit was connected.There was a slight buckle observed in the capsule nitinol reinforcing frame near the proximal section of the capsule, with multiple areas where the nitinol frame was exposed by small tears in the capsule outer layer.The deployment knob retracted the capsule, but could only advance the capsule as far as the spindle reaches the capsule buckle.The trigger moved to a fully retracted position, but could not reach a fully advanced position.The trigger locked in place when released.The tip-retrieval mechanism was intact, but could not be fully retracted as the spindle was caught by the capsule buckle.There was flattening to the distal end of the inner member shaft and a kink to the proximal end of the inner member shaft.There were two bends to the stability shaft.The reported event for unable to recapture could not be confirmed in the analysis as a valve could not be loaded due to device damage.The reported event for positioning difficulties could not be confirmed in the analysis.The reported event for buckle could be confirmed in the analysis.Conclusion: two procedural images were provided and an image review was completed.The first image shows the buckled capsule in the ascending aorta.The second image shows the buckled capsule along with the evolut valve partially deployed past the third node in the descending aorta.Recapturing is a feature of the device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Based on the information available, the cause of the difficulty recapturing was likely due to the pigtail catheter becoming stuck in between the valve and the capsule of the dcs.It is important to note that in training, it is advised to be cognizant of where the pigtail catheter is while one is recapturing to prevent this phenomenon from happening.Capsule buckle may occur due to excessive compressive forces applied to the capsule.Forces in the system is a cumulative effect that may be increased by factors such as tortuous anatomy and load quality.In this case, the capsule buckle likely occurred due to the pigtail catheter becoming stuck in between the valve and the capsule of the dcs.Updated: d9, h3, h6 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: ENVEO PRO DELIVERY SYSTEM
• 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: 16135178
• MDR Text Key: 308734669
• Report Number: 2025587-2023-00090
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENVPRO-14
• Device Catalogue Number: ENVPRO-14
• Device Lot Number: 0011454389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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 Sex: Male