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

Model Number ENVEOR-N

Device Problem Difficult to Advance (2920)

Patient Problems Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Death (1802)

Event Date 12/06/2018

Event Type  Death  

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) was discarded by the customer; 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 attempted implant of this transcatheter bioprosthetic valve with this delivery catheter system (dcs) and a non-medtronic introducer sheath, difficulty was encountered when crossing the aortic arch.As resistance was felt, the system was pulled back and rotated to help cross the aortic anatomy.Deployment of the valve was initiated and during deployment, respiratory arrest occurred.The valve was not yet fully deployed, was recaptured and was pulled back into the iliofemoral artery.Cpr was initiated, however, was unsuccessful, and the patient died.It was reported that the patient died of a stroke.The physician stated the aortic arch was heavily calcified and the dcs may have dislodged some calcium.The patient was reported to be in frail condition and high-risk.Following the procedure, the dcs was inspected and no damage was observed.An autopsy was performed, and the cause of death was confirmed to be the stroke.From the autopsy it was found that no damage to the aortic root anatomy or left ventricle occurred.

Manufacturer Narrative

Conclusion: the reported event indicates that there was difficulty advancing the dcs.Difficulties advancing the dcs through patient anatomy are known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity).In this case, it was noted that the aortic arch was heavily calcified.This indicated that the probable cause of the advancement difficulties was calcified patient anatomy.Deployment was attempted however the respiratory arrest occurred, and the patient died.It was reported that the patient died of a stroke.The physician stated the aortic arch was heavily calcified and the dcs may have dislodged some calcium.No damage to the dcs was reported.Multiple factors can influence the onset of a stroke.Its etiology may include embolization of calcific debris, patient medical history and procedural factors.¿stroke (ischemic or hemorrhagic), transient ischemic attack (tia), or other neurological deficits¿ are listed as potential adverse events associated with the use of the valve in the evolut system instructions for use (ifu).Based on the information available, an assignable root cause of the stroke could not be conclusively determined and the relationship to the device could not be established.There was no information to suggest a device malfunction or a failure to meet specifications that may have caused or contributed to this event.A dhr review is not required as the product event does not indicate a potential manufacturing issue.The device lot history record was not required as the product event does not indicate a potential manufacturing issue.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 R 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: 8203714
• MDR Text Key: 131638843
• Report Number: 2025587-2018-03578
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2019
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0009232899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death