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

Model Number EVOLUTR-23

Device Problems Gradient Increase (1270); Material Deformation (2976); Activation Failure (3270)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450); Swelling/ Edema (4577)

Event Date 08/03/2022

Event Type  Injury  

Manufacturer Narrative

Citation: ballout e, et al.Leaflet disruption of viv-tavi after bioprosthetic valve fracture leading to severe aortic regurgitation: a case report.European heart journal - case reports.2022 aug 3;6(8):ytac313.Doi: 10.1093/ehjcr/ytac313.Earliest date of publication 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.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 from a literature case report regarding a female patient who had a 23 mm medtronic evolut r transcatheter aortic valve (serial number not provided) implanted valve-in-valve in a stenotic 23 mm non-medtronic bioprosthesis.The immediate post-procedural mean transvalvular gradient was 34 mmhg, with minimal aortic regurgitation.Subsequently, a post-dilation was performed with an 18 mm balloon, but the mean transvalvular gradient remained.During the hospitalization following evolut r implant, a dual-chamber permanent pacemaker was implanted because of an alternating bundle branch block.Approximately four and a half years after evolut r implant, at the age of 84 years, the patient was admitted to the authors facility due to progressive worsening of heart failure symptoms, which consisted of elevated blood pressure (100/60 mmhg), dyspnea at rest, loud systolic ejection murmur radiating to the neck, diminished breath sounds in lower pulmonary fields on both sides, and bilateral leg edema.Echocardiography revealed transcatheter valve degeneration with severe stenosis (mean gradient of 50 mmhg) and moderate regurgitation.Left ventricle was dilated with decreased ejection fraction (30%) and the right ventricle was slightly dilated with reduced systolic function.Ca rdiac computed tomography showed under-expansion of the evolut r valve frame within the non-medtronic bioprosthesis.Despite intravenous diuretics during a one-week span, the patient¿s hemodynamics remained unstable.Consequently, bioprosthetic valve fracture (bvf) of the non-medtronic bioprosthesis was performed with a 22 mm balloon.The fracture was felt by the operator as a sudden drop in the balloon pressure, a visible release of the balloon, and an audible ¿click¿.Immediately following bvf, acute hypotension occurred.Aortography indicated severe aortic regurgitation.Transesophageal echocardiography showed severe intra-valvular aortic insufficiency/regurgitation caused by ¿disruption¿ to the one of the evolut r leaflets.The authors noted the leaflet disruption was a complication of the bvf intervention.Quickly, a 23 mm non-medtronic transcatheter aortic valve was implanted valve-in-valve in the evolut r, which resolved the aortic insufficiency and improved the patient¿s hemodynamics.At that time, echocardiography detected a mean transvalvular gradient of 33 mmhg without any aortic regurgitation.The patient was discharged thirteen days later in a st able condition.Six months later, the patient was asymptomatic and had experienced improvement of heart failure symptoms.No additional adverse patient effects or product performance issues were reported.

• 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: 15824450
• MDR Text Key: 303901088
• Report Number: 2025587-2022-03225
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female