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

Model Number D-EVOLUTFX-2329

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Rupture (2208); Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  Death  

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic valve, when withdrawing the delivery c atheter system (dcs), the nosecone caught on the valve.Subsequently, the valve dislodged into the aorta.An attempt at a second valve was made but the dcs could not pass through the first valve.In result, abdominal aortic damage occurred.Subsequently, hemorrhaging was observed.The patient was placed on extracorporeal membrane oxygenation (ecmo), and a catheter stent graft was performed to achieve hemostasis.Subsequently, asystole was observed, and the patient died.The cause of death was not provided.

Manufacturer Narrative

Concomitant medical products: product id: evolutfx-26, product analysis: the dcs was not returned and the valve remains implanted, 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 has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.Select patient information cannot be documented in the file due to regional privacy regulations.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: dislodgement of the valve by the distal tip is related to operator technique or experience.The device instructions for use (ifu), instructs ¿under fluoroscopic guidance, confirm that the catheter tip is coaxial with the inflow portion of the bioprosthesis¿ prior to drawing the delivery catheter system (dcs) tip through the valve.Per the physician, horizontal aorta and anatomical tortuosity contributed to the dislodgement.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications.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, the advancement difficulties were most likely due to interaction with the first valve.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.It was noted that the rupture occurred during insertion.Insertion was difficult.Difficulties inserting 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 stated that the cause of the aortic abdominal damage was due to tortuous anatomy and wire and the dcs was a contributing factor to the aortic damage.Vascular complications, such as bleeding, are known potential adverse patient effects per the device ifu.A variety of factors can contribute to the onset of asystole.In this case, it was noted the asystole was caused due to the abdominal rupture.A medical safety assessment was performed and based on the available information, the valve dislodgement was caused by the nosecone of the first dcs with tortuosity and aortic angulation contributing.The reported aortic rupture caused the hemorrhaging, asystole, and death.The aortic rupture was likely caused by anatomical tortuosity as well as difficulty advancing the dcs.All reported adverse events and severities are documented within the risk files and instructions for use.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications.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.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

Section d information references the main component of the system.Other relevant device(s) are: product id: d-evolutfx-2329, serial/lot: (b)(6) use by date: 2025.02.13, udi: (b)(4).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 reported that the abdominal aortic damage was classified as a rupture.It was noted that the rupture occurred during insertion.Insertion was difficult.According to the physician, the "deviation of the tortuous part" was the cause of the rupture.The patient had tortuous blood vessels and a horizontal aorta.

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.Updated data: b5.G2.H6.Patient code corrected data: h6.Eval code method additional codes: annex g 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.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 that prior to the valve implant via right transfemoral access, a pre-implant balloon aortic valvuloplasty (bav) was performed.Following the bav, using the cuspal overlap technique, slow deployment of the valve was observed.It was noted the delivery catheter system (dcs) was not twisted or torqued at any point during deployment.Subsequently, the valve was implanted in the native annulus.During the procedure, a non-medtronic guidewire was used.When withdrawing the dcs from the patient, the nose cone was centered within the frame inflow by slightly retracting the guidewire.However, interference of the nose cone caused dislodgement of the valve.Per the physician, horizontal aorta and anatomical tortuosity contributed to the dislodgement.Per the physician, the rupture caused and contributed to the patient¿s death.The cause of death was abdominal rupture.It was noted the asystole was caused due to the abdominal rupture.In addition, the cause of the aortic abdominal damage was due to tortuous anatomy and wire and the dcs was a contributing factor to the aortic damage.Percutaneous cardiopulmonary support was provided for the asystole.No adverse patient effects were reported.

• Brand Name: EVOLUT FX 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: 16993409
• MDR Text Key: 315852207
• Report Number: 2025587-2023-02182
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Date Device Manufactured: 03/15/2023
• 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): Required Intervention; Death