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

Model Number ENVEOR-N

Device Problem Failure to Advance (2524)

Patient Problems Stroke/CVA (1770); Thrombus (2101)

Event Date 04/09/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: e nveor-n, serial/lot #: (b)(4), udi#: (b)(4).Product analysis: the devices was discarded, therefore no product analysis can be performed.Conclusion: without the return of the products, 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 delivery catheter system (dcs) was advanced to the aorta but coaxial alignment was not achieved and the dcs was unable to advance through the annulus.A second dcs was attempted but the same issues occurred.The procedure was discontinued due to torque failing to be applied in blood vessel, abdomen and aortic arch.It was reported that the left ventricle was too small to properly place the medtronic guidewire.Approximately one week following the procedure, cerebral thrombosis occurred and was suspected to be caused partially due to insertion and removal of the dcs during the procedure.It was reported that heparin was not administered during the procedure.The patient underwent rehabilitation and was reported to be recovering well.No additional adverse patient effects were reported. .

Manufacturer Narrative

Conclusion: the devices were not returned.The reported event indicates that both delivery catheter systems (dcs) were unable to be advanced through the annulus.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the patients left ventricle was too small to properly place the medtronic guidewire.This may have contributed to the advancement difficulties, however a conclusive cause of the difficulties was unable to be confirmed given the limited evidence available.Vascular access related complications, such as thrombus, are a known potential adverse patient effect per the evolut system instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.) additionally a number of factors can affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient conditions, and its presence and rate of formation is largely dependent on patient condition.It was reported that heparin was not administered during the procedure, which may have contributed to the thrombus formation.However, based on the limited evidence available, an assignable root cause of the event cannot be determined and no relationship to the dcs could be established.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Updated data: h.6 - eval results and eval 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.

Manufacturer Narrative

Conclusion: the investigation was updated.Stroke is a known potential adverse effects per evolut system instructions for use.Strokes have many etiologies, including embolization of calcific debris, and is highly dependent on patient medical history and procedural factors.In this case, it was reported that the stroke may have been caused by the insertion and removal of the delivery catheter system (dcs) during the procedure.However, with the information available, an assignable root cause could not be determined and a relationship to the dcs cannot be established.Codes: annex e and f have been updated in this report.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 R DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10182889
• MDR Text Key: 196084921
• Report Number: 2025587-2020-01989
• 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
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0010077370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 90 YR
• Patient Weight: 45