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

Model Number ENVPRO-16

Device Problems Difficult to Remove (1528); Material Separation (1562); Separation Failure (2547)

Patient Problem Vascular Dissection (3160)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with the capsule partially opened.The tip-retrieval mechanism appeared intact.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.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The separation site was jagged and uneven.Conclusion: the investigation remains in progress.Following completion of the investigation, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve with this delivery catheter system (dc s), in a patient with aortic regurgitation (ar) and dilated root with a perimeter of 85 millimeter (mm), the valve was partially deployed and recaptured three times.The patient¿s pure ar caused the valve to dislodge on the three partial deployments.On the fourth deployment attempt, the handle was rotated to deploy the valve.The capsule was not retracting, and the valve was not able to be deployed.During the removal of the dcs, the dcs was difficult to remove and force was required to remove the dcs.The vessel tore due to the applied force to the damaged dcs.No treatment for the torn vessel was reported.The closure site was closed with a closure device.It was noted that the anatomy was calcified but was not tortuous.The dcs was inspected upon removal and the capsule was observed to be separated from the sheath.A new transcatheter bioprosthetic valve and dcs were used to complete the implant procedure.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.It was reported that was recapture three times due to valve dislodgement.Potential factors that can influence dislodgement include tension applied on the delivery catheter system (dcs) during positioning, calcification levels and shape of the native anatomy.The cause of the reported dislodgement could not be conclusively determined with the limited information available.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications.It was reported that a fourth deployment attempt was made.The evolut system instructions for use (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".During that fourth deployment attempt, the capsule was not retracting, and the valve was not able to be deployed.When the valve was inspected after removal, the capsule was observed to be separated.The subject 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.There was a break observed near the proximal end of the capsule frame, confirming the reported event.There was no other evidence of damage observed on the dcs.The investigation completed into capsule separation found that there is no evidence that the product fails to meet specification and these events are most likely not related to a fault condition of the device.The exact root cause of capsule separation is unknown, however, patient anatomy (vessel tortuosity <(>&<)> calcification) and use conditions due to challenging anatomy (insertion angle, force required to advance, torqueing of the catheter) are known contributing factors to capsule damage.Additionally, the four deployment attempts in this case, outside ifu recommendation, may have also caused or contributed to the capsule damage.It was reported that there was difficulty removing the dcs and force was required to remove the dcs.The vessel tore due to the applied force to the damaged dcs.Vascular injuries, such as dissection, are known potential adverse patient effects per the ifu, and may be impacted by many factors including the patient's pre-procedural condition and procedural factors, as well as factors related to the device.With no angiographic evidence for review, the cause of the injury and its relationship to the dcs, or the dcs capsule separation, cannot be confirmed.Updated data: h6 method and conclusion codes.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: 10008238
• MDR Text Key: 189322236
• Report Number: 2025587-2020-01502
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0010058014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR