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

Model Number ENVPRO-16

Device Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problems Intimal Dissection (1333); Death (1802); Blood Loss (2597)

Event Date 11/04/2019

Event Type  Death  

Manufacturer Narrative

Product analysis: the device was discarded; therefore, no product analysis can be performed.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 during the implant of this transcatheter bioprosthetic valve, the femoral vessel was pre-dilated using the dilator from the 16 f sheath.The delivery catheter system (dcs) was inserted and the access was difficult.The physician pulled on the wire for traction and the wire position got lost in the ventricle.The physician tried to push on the wire with no success.The valve was reported to be in an unusual position.The device was removed and hemostasis was unable to be obtained.A femoral bleed was reported due to pushing on the dcs and vascular support was called.The access was gained on the contra lateral side and a peripheral balloon was passed.A surgical cutdown repair was made.Access was obtained via a cutdown and the valve was deployed.The valve dislodged and was recaptured.The valve was deployed again and the valve dislodged again and was recaptured.The valve was deployed a third time in a deep position and was partially recaptured and redeployed and the valve slipped deeper.The valve was deployed for the fourth time in a deep position and the valve was partially recaptured.The valve was removed from the patient.A non-medtronic valve was implanted.Sizing was checked via transesophageal echocardiogram (toe).A dissection of the sinotubular junction/ascending aorta was noted and had extended into the descending aorta.It is unknown what caused the dissection or when the dissection occurred.The patient was intubated and placed on a ventilator.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that the surgical cutdown repair was made to repair the femoral artery (pli 40).The valve was then deployed with a new delivery catheter system (dcs) (pli 30).The patient died a few weeks later from a bleed.The cause of the bleed is unknown.Section d information references the main component of the system.Other relevant device(s) are: product id: envpro-16, lot: unknown, use by date: unknown, udi: unknown.Conclusion: difficulty inserting the dcs through the access vessel is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).In this case, the cause of the difficulty inserting could not be determined with the information available.It was reported that a femoral bleed was reported due to pushing on the dcs.Bleeding is a known potential adverse patient effects per the evolut system instructions for use (ifu), and may be impacted by many factors including the patient's pre-procedural condition and procedural factors.Procedural films were received for review (image review task 30).The imaging provided confirms there was difficulty trying to insert the system into the body.The imaging confirms excessive force was used to attempt to advance the catheter through the iliac on the right side.The excess force used to advance the dcs may have caused or contributed to the reported bleed.The ifu instructs "if there is a significant increase in resistance, stop advancement and investigate the cause of the resistance (for example, magnify the area of resistance) before proceeding.Do not force passage.Forcing passage could increase the risk of vascular complications (for example, vessel dissection or rupture)".The procedural films received for review confirmed the reported deep deployment, however the valve recaptures are not imaged for this event.The 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".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 and dislodgement do not typically indicate a device malfunction or a failure to meet manufacturing specifications.The procedural films received for review confirmed that after the deployment of the non-medtronic valve, a dissection was seen and confirmed with an angiogram.Cardiovascular 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.It is unknown what caused the dissection or when the dissection occurred.Based on the limited information available, an assignable root cause of the injury cannot be determined and the relationship to the dcs could not be established.The patient died a few weeks later from a bleed.It was reported that the cause of death is unknown, and therefore, the potential relationship the dcs cannot be established.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.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: 9378670
• MDR Text Key: 185208661
• Report Number: 2025587-2019-03605
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009829370
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention