MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number D-EVPROP23-29

Device Problems Failure to Advance (2524); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Date 02/25/2023

Event Type  Death  

Manufacturer Narrative

Product analysis: the device was discarded and no procedural images were submitted for review; 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.

Event Description

Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve, in a patient with tortuous anatomy, the patient's average heart rate was 180bpm.A non-medtronic guidewire was used for the procedure. the delivery catheter system (dcs) was advanced towards the aortic arch, but failed to cross successfully.The valve implant team retracted the dcs and rotated it to alter the catheter spines and then readvanced around the aortic arch.This process was attempted three times with no success.The valve implant team decided to overdrive the nose cone of the dcs and applied gentle pressure to try again.The dcs advanced further, but did not cross the aortic arch.The patient's systolic blood pressure dropped to approximately 20 mm hg.A vasopressor medication was administered.The patient went into pulseless electrical activity.Cardiopulmonary resuscitation was commenced using a lucas device.However, resuscitative efforts were unsuccessful; the lucas device was retracted and removed.Subsequently, the patient died.

Event Description

Additional information was received which reported that the drop in blood pressure was a result of an aortic dissection.The physician was speculating that the push applied to advance the dcs around the arch resulted in an aortic dissection, ultimately resulting in patient death.An autopsy will be performed to confirm the cause of death.

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.

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.

Event Description

Additional information was received which corrected the previously reported information: the patient's average blood pressure was 180 mmhg.

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) was discarded, and therefore no product analysis could be performed.Conclusion: difficulties advancing the dcs through the vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.Hypotension is a known potential adverse effect per device instructions for use (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.A vasopressor medication was administered.Vascular related complications, such as aortic dissection, are a known potential adverse patient effect per the evolut system ifu and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.In this case, it was reported that pressure was applied when attempting to cross the aortic arch with the dcs.The evolut system ifu instructs "do not force passage".Persistent force on the catheter can cause damage to the catheter or the patient.Cardiovascular injuries, such as cardiac arrest, are 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, as well as factors related to the device.A medical safety assessment was carried out for this complaint.Upon review of the information provided, the aortic dissection leading to death is related to the evolut pro valve+ dcs.The physician was speculating that the push applied to advance the dcs around the arch resulted in an aortic dissection, ultimately resulting in patient death.Contributing factors was the patient's tortuous anatomy.Aortic dissection and death are known potential risks associated with the implantation of the evolut pro+ valve and the death and aortic dissection and appropriate severities are documented in the evolut pro+ risk files and instructions for use.No further safety assessment is required at this time.A device history record (dhr) review was performed on the dcs and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.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.

• Brand Name: EVOLUT PRO PLUS DCS
• 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: 16475692
• MDR Text Key: 310583610
• Report Number: 2025587-2023-00786
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: D-EVPROP23-29
• Device Catalogue Number: D-EVPROP23-29
• Device Lot Number: 0011474207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Date Device Manufactured: 10/27/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Sex: Female