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

Model Number ENVEOR-L

Device Problems Material Separation (1562); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Cardiac Arrest (1762); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Blood Loss (2597); Vascular Dissection (3160)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: evolutr-29, serial #: (b)(4), ubd: 05-mar-2022, udi#: (b)(4).Product analysis: the products were discarded, therefore no product analysis can be performed.Conclusion: without 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 following the implant of this transcatheter bioprosthetic valve, cardiac arrest occurred.Dissection was observed on the non-coronary cusp (ncc) side of the ascending aorta and cardiac tamponade occurred, which was treated using cardiac massage and pericardial drainage.However, the bleeding did not stop, and thoracotomy was subsequently performed to replace the valve with a non-medtronic valve and repair the dissection.Two days following the valve implant, hemodynamics were reported to be stable.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information reported that the dissection occurred in the ascending aorta region when a level difference, described as a gap between the nosecone and the capsule of the delivery catheter system (dcs) appeared.Fluoroscopic imaging was reviewed following the procedure and noted that the dissection occurred when the dcs passed through the ascending aorta.The patient¿s horizontal anatomy and fragile blood vessels due to ascending expansion contributed to the injury.The valve did not cause or contribute to the dissection or subsequent cardiac tamponade.However, the valve was replaced due to the surgical intervention that was required to replace the ascending aorta.The valve frame was in the way and needed to be removed.Updated h6 - device 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

Additional information was received clarifying that the dissection was caused by the nose cone when passing through the level difference at the origin of the horizontal aorta.The dcs was withdrawn from the patient without issue.Updated data: d8, g1, h6 corrected: h8, removal of c62964 code from h6.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

Additional information was received that following the procedure, a cerebral infarction and disuse atrophy progressed.The patient was rehabilitated and transferred to the hospital.No additional adverse patient effects were reported.Updated 2 - outcome attributed to adverse event.Updated h.6 - patient code and health impact code.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.It was reported that the dissection occurred in the ascending aorta region when a level difference, described as a gap between the nosecone and the capsule of the delivery catheter system (dcs) appeared, which caused difficulties advancing.The subject delivery catheter system (dcs) was discarded by the customer, and as such no analysis could be performed.No procedural images were provided for review.Difficulties advancing the dcs is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuosity, etc.).In this case, the patient presented with a horizontal aorta.This indicates the probable cause of the difficulties advancing is patient anatomy.However, without procedural images for review the cause of the difficulty advancing the dcs could not be determined with the information available and a relationship to the dcs cannot be established.The device instructions for use (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).Cardiovascular complications, such as bleeding, dissection, cardiac tamponade and cardiac arrest, are all known potential adverse patient effects per the device 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.).In this case, it was noted that the patient had horizontal anatomy and fragile blood vessels.This indicates that the probable cause of these complications was due to patient anatomy.However, based on the limited information available, an assignable root cause of the cardiovascular complications cannot be determined and the relationship to the dcs could not be established.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Stroke is a known potential adverse effects per device instructions for use.Ischemic strokes have many etiologies, including embolization of calcific debris, and is highly dependent on patient medical history and procedural factors.However, with the limited information available, an assignable root cause could not be determined and a relationship to the dcs cannot be established.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 DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10622387
• MDR Text Key: 209660189
• Report Number: 2025587-2020-03003
• 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,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: ENVEOR-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: 0010192245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 85 YR
• Patient Weight: 31