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

Model Number ENVPRO-16

Device Problems Fracture (1260); Material Separation (1562); Difficult to Advance (2920); Material Split, Cut or Torn (4008); Firing Problem (4011)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the product has not yet been returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn 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 a 34-millimeter (mm) transcatheter bioprosthetic valve with this delivery catheter system (dcs), the system was introduced in a mid-tortuous anatomy, with suitable vessel diameters.It was found to be harder than usual to reach the aortic root with the capsule.The operators rotated the system with 90 degrees at least twice and the valve was implanted on the first deployment attempt.When the dcs was withdrawn to the descending aorta, it was noted that a fracture at the proximal end of the capsule was present.The dcs was removed and the capsule was examined.The capsule was confirmed to have been split open along its full circumference.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with the capsule fully closed and the end cap/screw gear snap fit connected.The handle and tip-retrieval mechanism appeared intact.The inner member shaft and spindle hub appeared intact with no evidence of damage.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.Several voids were observed over the nitinol reinforcing frame along the distal end to the proximal end of the capsule.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule, the capsule was held together by the outer layer of polymer.Torsion marks were observed on the outer shaft near the capsule.The spine of the dcs was broken at the strain relief near the front grip of the handle.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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 there was difficulty advancing the delivery catheter system (dcs).Difficulties advancing the dcs through patient anatomy is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).In this case, it was noted that the anatomy had some tortuousity.Angiographic records were received for review which confirmed the torturous vessels.This indicates that the most likely cause of the advancement difficulties was tortuous patient anatomy.The angiographic records submitted for review did not confirm the capsule break.Capsule separation occurs when excessive compressive force is applied to the capsule.Historically, this excessive compressive force is experienced when the valve is loaded incorrectly.The fluoroscopic load check from this case was not submitted for review, therefore it could not be determined if the load was good.The root cause of the capsule break in this event cannot be conclusively confirmed.The compressive force on the system, which can cause a capsule to break, is a cumulative effect that may have been increased by factors such as tortuous access vessels.Additionally, analysis of the returned dcs observed delamination on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy, or if a valve has been misloaded.Torque marks were observed on the dcs, and it was observed that the spine of the dcs was broken at the strain relief.It was reported that the operator rotated the system 90 degrees at least twice which is the most likely cause of the torsion marks.Historically, torqueing or manipulation of the dcs against the spine wires by the operator may cause the spine wire to break.Torqueing of the dcs may have also increased the stress on the system.The evolut system instructions for use (ifu) instructs "do not rotate the catheter as it is advanced".There was no other evidence of damage on the dcs.Overall, there were no findings to suggest a device quality deficiency related to the manufacturing of the device.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 7746459
• MDR Text Key: 116238819
• Report Number: 2025587-2018-01979
• 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,Followup,Followup
• Report Date: 02/14/2019

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: 03/13/2020
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009033555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 09/06/2018; 08/08/2018; 02/08/2019
• Supplement Dates FDA Received: 09/26/2018; 10/03/2018; 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other