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

Model Number ENVPRO-16

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Anemia (1706); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pseudoaneurysm (2605)

Event Date 11/07/2019

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, cardiac tamponade was reported due to left ventricular perforation.The cause of the perforation was not reported.The procedure was converted to open heart surgery and direct suture of the perforation was performed.A disabling ischemic stroke of modified rankin score (mrs) 5, aphasia and dysarthria were reported.The cause of the stroke was not reported.A percutaneous transluminal angioplasty (pta) with a 6 x 40 balloon (armada) was used at the left femoral access site due to a femoral pseudoaneurysm and surgical closure was performed.Anemia was reported and eight units of blood were transfused.The cause of the anemia was not reported.Of note the patient's minimum diameter access vessel was 6.7 mm.No additional adverse patient effects were reported.

Manufacturer Narrative

Relevant device(s) are: product id: e volutpro-26, serial/lot #: (b)(4), ubd: 2020-03-14 , udi#: (b)(4).Product analysis: the valve remains implanted and the dcs was not returned, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.

Event Description

Additional information was received which reported that the lv perforation was caused by the guidewire (non-medtronic).

Event Description

Additional information was received which reported that according to the physician, neither the valve or the delivery catheter system (dcs) contributed to the tamponade.As a result of the stroke, hypotension and subsequent cerebral hypo-perfusion were reported.The cardiac tamponade contributed to the stroke.

Manufacturer Narrative

Updated b5.Updated 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

Updated data: h6 - results and conclusion codes h10 - conclusion: a medical safety assessment was performed and upon review of the information provided and per the implanting physician's assessment, the left ventricle (lv) perforation was not related to the evolut r valve or delivery catheter system (dcs) but was related to a non-medtronic (mdt) guidewire.Upon review of the information provided, the femoral access site pseudoaneurysm is not related to the evolut r valve however, relatedness to the dcs is unknown.Vascular complication, including ventricular perforation, and access site complication, including pseudoaneurysm, are known potential risks associated with the implantation of the evolut r valve and all reported adverse events (ae) and appropriate severities are documented in the risk management files and instructions for use.The subject dcs was not returned to medtronic for analysis and as such no analysis could be performed.Procedural images were not provided for review.Cardiac tamponade, bleeding, perforation and pseudoaneurysm, are known potential adverse patient effects per the evolut pro 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.).In this case, it was reported that the lv perforation was caused by the guidewire (non-medtronic).Per the physician, neither the valve nor the delivery catheter system (dcs) contributed to the tamponade.As a result of the stroke, hypotension and subsequent cerebral hypo-perfusion were reported.The cardiac tamponade contributed to the stroke.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.The lv perforation resulted in the secondary/cascading event of cardiac tamponade and stroke (due to cerebral hypoperfusion and hypotension from the cardiac tamponade).In addition, there was a femoral access site pseudoaneurysm that required surgical intervention which is not related to the lv perforation.Unable to assess relatedness of the dcs to the vascular complication but it is not related to the valve.The patient had significant bleeding requiring 8 units of packed red blood cells (prbcs).Most likely due to the combination of the lv perforation and vascular injury.Stroke is a known potential adverse effect per the device ifu, with a variety of factors that can influence its onset.It was reported that the cardiac tamponade contributed to the stroke.No treatment was reported.Hypotension is a known potential adverse effect per the device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.The patient has a history of dyslipidemia and hypotension, which ae likely contributing factors.No treatment was reported.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.This event does not allege a device misuse or malfunction occurred.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 DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16020291
• MDR Text Key: 305873843
• Report Number: 2025587-2022-03650
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Date Device Manufactured: 04/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10....".
• Patient Outcome(s): Disability; Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG