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

Model Number ENVPRO-14

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Material Protrusion/Extrusion (2979); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was received loaded in the capsule of the delivery catheter system (dcs).The device was received with the tip retrieval components detached from the dcs.The male tip retrieval component was not received with the dcs.The deployment knob could not retract or advance the capsule.The trigger moved to the fully advanced and retracted positions and locked in place when released but was unable to retract or advance the capsule.The capsule was received partially opened.There was damage noticed on the threading of the screw gear.The device was returned with the end cap/screw gear snap fit connected.Delamination was observed over the nitinol reinforcing frame along the full length of the capsule.Torsion marks were observed on the outer shaft.The spine of the dcs was broken approx.7.5 cm proximal to the capsule.The valve could not be removed from the dcs.Conclusion: the investigation is in progress.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 transcatheter bioprosthetic valve, into an annulus measuring 22 mm with moderate calcification and left ventricular outflow tract (lvot) calcification, a pre-implant balloon aortic valvuloplasty (bav) was performed.During the implant, the valve was recaptured once due to high positioning.The physician attempted to turn the delivery catheter system (dcs) to the outer curve by turning 90 degrees.Tension was felt in the system and a "knock" noise was heard.Opening of the capsule to deploy the valve was not possible as the deployment mechanism failed.Turning the deployment knob had no effect on the capsule.The system was safely removed and replaced for successful implant.Per the physician, it was assumed that the spine shaft broke.It was reported that friction was felt when advancing the dcs.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.The reported event indicates that the valve was recaptured once due to sub-optimal positioning.Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.It was reported that, after the attempt to turn the dcs by 90 degrees, a noise was heard and deploying the valve was not possible.The dcs was returned to medtronic for analysis.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through patient anatomy.The device was received with the tip retrieval components detached from the dcs and the components were not returned with the dcs.The description of the event does not indicate that this damage occurred during the reported issue.The components may have been detached after the event occurred, however the cause cannot be conclusively determined with the information available.The handle could not retract or advance the capsule, confirming the reported inability the deploy the valve reported in the event.There was damage observed on the screw gear threading in the dcs handle.This damage indicates there was increased forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.The force in the system is a cumulative effect that can be increased by many factors, including load quality of the valve in the capsule, bends and kinks on the shaft, tortuous anatomy and guidewire and sheath selection.There was torsion marks observed on the outer shaft and the catheter spine wire was observed to have broken.Historically, torquing or manipulation of the dcs against the spine wires by the user may cause the spine wire to break.The ifu instructs t he user not to rotate the dcs as is being advanced.Spine wire break is consistent with the reported information that during attempted deployment the capsule did not move.When the spine wire breaks the force from the handle is not transmitted to the capsule.The user may have torqued the device to due to the reported tortuous anatomy which may have damaged the spine.The system was safely removed and replaced for successful implant.There is no information to suggest that a device quality deficiency may have caused or contributed to this event.Updated data: h6- eval method code and eval 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: ENVEO PRO DELIVERY SYSTEM
• 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: 9649478
• MDR Text Key: 181978068
• Report Number: 2025587-2020-00326
• 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: 04/20/2020

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: 10/29/2021
• Device Model Number: ENVPRO-14
• Device Catalogue Number: ENVPRO-14
• Device Lot Number: 0009992254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1