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

Model Number EVOLUTR-26-US

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 10/06/2022

Event Type  Death  

Manufacturer Narrative

Product analysis: the device 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 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 four years and ten months following the implant of this transcatheter bioprosthetic valve, a second valve was implanted for an unknown reason.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated b2.Updated date of death.Updated b5.Updated h1.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.

Event Description

Additional information was received that the second valve was implanted as a result of symptomatic, severe, aortic valve insufficiency (ai) due to degeneration of the transcatheter valve.The patient experienced chronic heart failure and ventricular tachycardia as a result of the severe ai.The implant of the second valve resolved the reported regurgitation, however approximately 10 minutes following the replacement valve implant, the patient started to complicate with supra-systemic pulmonary hypertension and right ventricle (rv) heart failure.Subsequently the patient died 2.5 hours following the implant procedure.The cause of death was most likely attributed to secondary supra-systemic pulmonary pressure overload.

Manufacturer Narrative

Conclusion: no images of the implantation procedure or the implanted valve were available for medtronic review and the valve was not returned to medtronic for product analysis.A medical safety review was performed.The following is a brief synopsis of its findings: based on the information provided, the need for a secondary transcatheter aortic valve (tav) placement and subsequent cascading events, including death, is related to the initial tav device as information notes degeneration of this valve resulting in aortic insufficiency (ai).It is not clear what the specific bioprosthetic valve degeneration is, however.The second//replacement tav was placed off-label as the device is not approved to treat ai.The placement of a second//replacement tav, although successful, lead to the procedural complication of supra-systemic pulmonary hypertension and rv failure and death.Hypertension is a known potential adverse effect per the device instructions for use (ifu), with a variety of factors that can influence its onset.Regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.Structural valve dysfunction is a known potential adverse effects per the evolut ifu.Several factors can contribute to the onset and propagation of either failure mechanism such as patient medical history (age, disease stage, comorbidities, etc.), pharmacological factors, and/or intrinsic properties of the valve itself.With the limited information available, a conclusive root cause could not be determined but the patient¿s medical history may have been a contributing cause.Subsequently the patient died 2.5 hours following the implant procedure.The cause of death was most likely attributed to secondary supra-systemic pulmonary pressure overload.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.Review of the device history record (dhr) for this device found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.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.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC 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: 15794610
• MDR Text Key: 303623993
• Report Number: 2025587-2022-03186
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169637993
• UDI-Public: 00643169637993
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

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: 11/16/2018
• Device Model Number: EVOLUTR-26-US
• Device Catalogue Number: EVOLUTR-26-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 03/16/2023
• Supplement Dates FDA Received: 01/05/2023; 03/20/2023
• Date Device Manufactured: 12/05/2016
• 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): Hospitalization; Life Threatening; Death; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female