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

Model Number EVOLUTR-29-US

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Cardiac Arrest (1762); Cardiogenic Shock (2262); Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/10/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: the valve remains in the patient, therefore product analysis cannot be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that four years, eight months, twenty-three days following the implant of this transcatheter bioprost hetic valve, the patient presented with moderate-severe central aortic insufficiency (ai) and a possible failed leaflet.The failing leaflet was based on the physician's assessment of the films and was not been definitively confirmed.The cause of the failed leaflet is unknown.No treatment was performed for the ai nor the failed leaflet.Four years, nine months following the valve implant, the patient died from cardiogenic shock related to severe ai and cardiopulmonary arrest.Per the physician, the valve contributed to the patient's death.No autopsy was performed.

Manufacturer Narrative

Conclusion: the device history record was reviewed.And showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Moderate aortic regurgitation was reported after deployment with the valve looking markedly under deployed.Aortic regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.And a conclusive cause could not be determined from the limited information available.Per the instructions for use (ifu), in the event that valve function or sealing is impaired, due to excessive calcification or incomplete expansion, a post implant balloon dilatation of the valve may improve valve function and sealing.To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation.The balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.Review of the echocardiogram/transesophageal echocardiogram (tee) photo clips related to this event found the following: there is no imaging provided to confirm, the procedure day of implant.Nor can confirm, the post bav¿s as stated in this event report.The tee/echo, that is provided for this event confirms, there is moderate to severe aortic regurgitation present and can be seen with color flow doppler in the short and long axis views.The tee doppler tracings recorded confirm, this is severe aortic regurgitation.The 3d tee reconstruction confirms, a partial flail leaflet in the short axis view.Preliminary assessment suggest that the post valve deployment interventions were possibly among the factors leading to the damage of the valve leaflet.However, without angiographic imaging of the initial implant procedure, we are unable to conclusively determine the exact cause of for the reported failed leaflet that reported to have presented with moderate/ severe central aortic insufficiency (ai).The report of patient expiration at four years, nine months post-implant was ascertained as being related to the procedure, specifically from cardiogenic shock related to ai and cardiac arrest.As neither an autopsy nor an explant was performed, a conclusive assessment of the relationship between the event and the device could not be reached.A procedure or valve-related death is an inherent risk, when the patient condition is such that a pav is needed to sustain cardiac function.And it can occur despite an ideal implant procedure or device functionality.Updated h.6 0 eval method, eval results, eval conclusion codes.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 DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10864618
• MDR Text Key: 217059694
• Report Number: 2025587-2020-03573
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169638006
• UDI-Public: 00643169638006
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: EVOLUTR-29-US
• Device Catalogue Number: EVOLUTR-29-US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR