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

Model Number ENVPRO-16

Device Problems Material Separation (1562); Positioning Problem (3009)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

No product was returned.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the attempted implant of a 34 millimeter (mm) transcatheter bioprosthetic valve, after four to five recaptures due to difficult placement, the delivery catheter system (dcs) capsule broke.The recaptures were noted to be performed due to the valve being unstable during placement.The valve was either too high or too low.As result of the capsule break, the system was removed from the patient and a new system was used.A 29mm valve was chosen due to less calcification and was successfully implanted.Of note, the patient had a small anatomy and less calcification on the annulus that may have contributed to the capsule break.No loading difficulties or a misload were identified.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the handle was intact.The device was received with the capsule partially opened.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The separation site was observed to be jagged and uneven.The deployment knob could not advance or retract the full capsule due to the separation.The trigger moved to fully advanced and retracted positions and locked in place when released with resistance noted.The tip-retrieval mechanism was intact however the tip could not be retracted due to the capsule separation.The device was returned with the end cap/screw gear snap fit connected.There was damage observed on the threading of the screw gear.Delamination was observed over the nitinol reinforcing frame along the mid-section of the separated part of the capsule.There was a bend visible to the middle shaft.Updated 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.

Manufacturer Narrative

Conclusion: the subject delivery catheter system (dcs) was returned to medtronic for analysis.The device was received with the capsule partially opened.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The separation site was observed to be jagged and uneven.The deployment knob could not advance or retract the full capsule due to the separation.The tip-retrieval mechanism appeared intact however the tip could not be retracted due to the capsule separation.There was damage observed on the threading of the screw gear.This damage is consistent with the increased forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.Delamination was observed over the nitinol reinforcing frame along the mid-section of the separated part of the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.There was a bend visible to the middle shaft, however the description of the event does not indicate that this damage occurred during the reported issue.Middle member shaft kinks have historically been observed when the device was returned for analysis with the capsule open and no stylet in place to support the shaft.Procedural images were provided for review.The valve load inspection was not provided.There is no imaging of a broken capsule.The reported events of positioning difficulties and capsule separation could not be seen in the images provided.The reported event indicates that the valve was recaptured four to five times due to difficult placement.Recapturing is a feature of the evolut pro system 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 that a device quality deficiency may have caused or contributed to this event.It was reported that, after the four to five recaptures, the dcs capsule broke.Capsule separation can occur due to excessive compressive forces applied to the capsule.Force in the system is a cumulative effect that may be increased by factors such as tortuous anatomy and load quality.In this case, it was reported that the patient had a small anatomy and less calcification on the annulus that may have contributed to the capsule break.It was also noted that the capsule separation occurred after four to five recaptures.The evolut pro ifu instructs ¿deployment of the bioprosthesis can be attempted 3 times.If the bioprosthesis is recaptured a third time, it must be removed from the patient.This indicates off label use.There was no information to suggest that a device malfunction or a failure to meet manufacturing specifications was related to these events.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: 15812434
• MDR Text Key: 303899324
• Report Number: 2025587-2022-03210
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0010961453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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: 54 YR
• Patient Sex: Female