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

Model Number EVOLUTR-29

Device Problem Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Fistula (1862); Valvular Insufficiency/ Regurgitation (4449)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Citation: hoppmann p, et al.Right ventricular fistula post-tavr: amenable to interventional closure treatment.Clin res cardiol.2017 oct;106(10):846-848.Doi: 10.1007/s00392-017-1130-1.Epub 2017 jun 27.Earliest date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature case report regarding a (b)(6) female patient who underwent implant of a 29 mm medtronic evolut r transcatheter valve (unique device identifier number not provided).Following valve deployment, a post-dilation was performed with a 26 mm non-compliant balloon because of ¿significant¿ paravalvular regurgitation.Afterward, the regurgitation was reduced to a grade i (mild).Pre-discharge transthoracic echocardiography revealed a small aorto-right ventricular fistula, which did not require treatment.Three months later, the patient reported aggravating dyspnea at a cardiology visit.Echocardiography showed normal function of the evolut r valve, but color-flow doppler echocardiography revealed a high-velocity jet from the aortic root into the right ventricle.The patient was referred to the authors facility where angiography of the aortic root confirmed a broad fistula from the right coronary cusp into the right ventricle.Right heart catheterization revealed a left-right shunt.Subsequently, percutaneous intervention was performed and a non-medtronic ductal occluder was placed, which completely closed the fistula.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Updated information: b5.Additional information received from the corresponding physician/author stated it is thought by all the authors that the evolut r caused the fistula, but they don't know specifically how it caused the injury because they did not perform the valve implant.The corresponding physician/author also stated, "it is possible that the valve frame injured the aortic wall, and subsequently, due to high pressure in the area, this minimal lesion expanded ¿ at least that's what was detected in echocardiography." 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 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: 14047409
• MDR Text Key: 289018487
• Report Number: 2025587-2022-00936
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female