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); Material Separation (1562); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

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.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, the valve was loaded without difficulty and confirmed with fluoroscopy.During the first deployment attempt, the position was unsatisfactory, however it was noted that the valve had been deployed to the point of no recapture.It was attempted to recapture the valve and the capsule separated at the level of the paddle pockets.The valve was able to be recaptured and the system was retrieved.A new system was used for successful implant.Brightening along the capsule was reported and part of the nitinol frame was protruding.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 valve loaded in the capsule.The handle was intact.The device was received with the capsule separated and partially retracted.The deployment knob was able to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The device was returned with the end cap/screw gear snap fit connected.Delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule near the separation site.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.The capsule could not be removed from the dcs.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 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 "brightening along the capsule" reported in the event is most likely describing the delamination.Delamination 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 capsule separation.The separation site was observed to be jagged and uneven, which may be the "nitinol frame was protruding" reported in the event.It was reported that during the first deployment attempt, the position was unsatisfactory.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.The valve was attempted to recaptured, however the valve had been deployed to the point of no recapture.Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.The evolut system instructions for use (ifu) instructs "once the radiopaque capsule marker band reaches the distal end of the radiopaque paddle attachment (point of no recapture), retrieval of the bioprosthesis from the patient (for example, use of the catheter) is not recommended.Retrieval after the point of no recapture may cause mechanical failure of the delivery catheter system, aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery".The capsule separated during the attempt to recapture the valve.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 ana tomy (vessel tortuosity <(>&<)> calcification) and use conditions due to challenging anatomy (insertion angle, force required to advance, torqueing of the catheter) are known potential contributing factors to capsule damage.In this case, the potential recapture after the point of no recapture may have damaged the capsule.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

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: 9531466
• MDR Text Key: 181981428
• Report Number: 2025587-2019-03916
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 0009992252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1