MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number ENVEOR-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 05/01/2019

Event Type  Injury  

Event Description

Medtronic received information from a literature case report regarding a patient who underwent transcatheter aortic valve replacement with a 29 mm medtronic evolut r system via the right subclavian artery access site.Prior to insertion of the evolut r system, a 14-french dilator was used to dilate the subclavian artery.Following valve deployment, aortography showed moderate paravalvular leak (pvl) and a balloon post-dilation was planned.The enveo r delivery catheter system was withdrawn from the right subclavian artery and a 14-french sheath and balloon catheter were advanced, but resistance was encountered.Aortography revealed a right subclavian artery dissection and extravasation of contrast around the subclavian artery and aortic arch.The patient¿s mean arterial blood pressure decreased (104 to 36 mm hg).Multiple boluses of norepinephrine and vasopressin were administered, and a norepinephrine infusion was started to normalize the patient¿s blood pressure.Concurrently, peak inspiratory pressures increased from 15 to 35 mm hg with decreased tidal volumes (maximum volumes of 50 to 200ml).Manual ventilation via a bag valve mask was initiated and allowed delivery of larger tidal volumes to the patient and stabilization of respiratory status, suggesting that the ventilation changes were procedure related.A transesophageal echocardiography probe was emergently placed, which revealed a hematoma surrounding the distal aortic arch and descending thoracic aorta without evidence of an aortic dissection.Fiberoptic bronchoscopy showed the posterior membranous trachea bulging forward from the level of the midtrachea extending down to the carina, consistent with external compression from the periaortic hematoma.This compression caused a decrease of approximately 75% in the area of the trachea.Subsequently, two subclavian artery stents were deployed, which stopped further bleeding.Ventilation via a bag valve mask was continued due to high inspiratory pressures.Because of continued difficulty in ventilating the patient, an incision was made along the right sternocleidomastoid muscle and dissected inferiorly down to the mediastinal space.Evacuation of the mediastinal hematoma improved ventilation, normalizing peak inspiratory pressures and allowed the patient to be placed back on the mechanical ventilator.The patient was then transported to the cardiothoracic intensive care unit intubated and sedated.The patient was extubated on post-operative day one, transferred out of the intensive care unit on post-operative day four, and ultimately discharged home in good condition on post-operative day seven.Post-operative transthoracic echocardiogram one month later exhibited a well-positioned aortic bioprosthesis with only trace pvl.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: deandrade ds, et al.Airway compression during transcatheter aortic valve replacement via subclavian artery approach: a case report.A<(>&<)>a practice.2019 may 1;12(9):329-331.Doi: 10.1213/xaa.0000000000000927.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.

• Brand Name: ENVEO R DELIVERY SYSTEM
• 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: 16274036
• MDR Text Key: 308500898
• Report Number: 2025587-2023-00356
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ENVEOR-US
• Device Catalogue Number: ENVEOR-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 55 KG