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

Model Number EVPROPLUS-34

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Aneurysm (1708); Vascular Dissection (3160); Multiple Organ Failure (3261)

Event Date 01/30/2023

Event Type  Death  

Manufacturer Narrative

Continuation of concomitant medical products: the main component of the system.Other relevant device(s) are: product id: d -evprop34, serial/lot #: (b)(4), ubd: 14-sep-2023, udi#: (b)(4).Product analysis: the valve remains implanted and the delivery catheter system (dcs) 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.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 implant of this transcatheter bioprosthetic valve , the valve dislodged at 80% deployment and was recaptured.The valve was repositioned in optimal position while pacing was used to stabilize valve movement.After the valve was released an aortic dissection was observed from the top crowns of the valve down to the abdominal aortic aneurysm.The patient was stable and dissection was confirmed on computed tomography (ct) following the valve implant.The surgical team turned the patient down for surgical intervention for the dissection.The patient died four days later.The physician suggested multi-organ failure following the dissection.

Manufacturer Narrative

Additional information was received that the abdominal aortic aneurysm existed prior to the valve procedure.The aortic dissection occurred post valve deployment and was due to oversizing of the valve and was confirmed via a computed tomography (ct).It was reported that the ct sizing showed the incorrect valve size.On resizing, the valve that should have been used should have been one size smaller.Due to the valve oversizing, the physician believes the valve contributed to the death.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: no procedural images were provided and the valve was not returned to medtronic, therefore no analysis could be performed.Per the device instructions for use (ifu), the bioprosthesis size must be appropriate to fit the patient¿s anatomy.Proper sizing of the device is the responsibility of the physician.Refer to table 1 of the ifu for available sizes.In this case, the physician implanted a larger valve that what was required.Thus, the root cause was use-related.Potential factors that can influence dislodgement include tension applied on the dcs during positioning, calcification levels and shape of the native anatomy.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Vascular complications, such as dissection, are a known potential adverse effect per device ifu and can occur during the implant pro cedure, with a varying risk that is dependent on several factors such as the access point for the implant, the patient's state of health, and pre-existing medical conditions.With the limited information made available, the cause of the dissection can be attribute d to the mis-sized valve.The larger valve expanded causing the aortic dissection.The patients¿ pre-existing comorbidities likely contributed to the dissection as well.The cause of the dissection was use-related as it was the larger valve that caused the dissection.No official cause of death was reported.The physician believed that the valve contributed to the death of the patient.Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a tav is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.In this case, the valve was incorrectly sized, causing an aortic dissection which ultimately lead to the death of the patient.Thus, this is a use-related cause.A device history record (dhr) review was performed on the device and all process parameters were within specification as outlined in applicable procedures and specifications.All materials used were as per the requirements of the dhr.All processes were carried out as per relevant procedures and device met specifications.Dhr review did not show any deviations in the manufacturing process.A dhr was not performed on the delivery catheter system (dcs).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 VALVE
• 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: 16340081
• MDR Text Key: 309251049
• Report Number: 2025587-2023-00477
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: EVPROPLUS-34
• Device Catalogue Number: EVPROPLUS-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 02/24/2023; 05/08/2023
• Supplement Dates FDA Received: 03/02/2023; 05/08/2023
• Date Device Manufactured: 05/06/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Sex: Male