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

Model Number EVOLUTR-29

Device Problem Activation Failure (3270)

Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficiency, Valvular (1926); Perforation (2001); Blood Loss (2597); Pericardial Effusion (3271)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted; therefore, no product analysis could be performed.  conclusion: paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, calcification level or presence of pre-existing patient conditions.In this case, it was reported that the moderate pvl was noted post implant and the valve was not fully expanded.This indicated that incomplete frame expansion could be a contributing factor for the pvl.A balloon aortic valvuloplasty (bav) was performed, pvl had reduced to trivial and it was noted that the valve had expanded.Multiple factors can affect frame expansion, such as patient anatomy (e.G., calcification location and levels) and procedure related factors (e.G., valve positioning).Based on the information provided, an assignable root cause of the frame incomplete expansion could not be conclusively determined.The device history record and associated frame lot was reviewed and showed that this device met all manufacturing specifications for final product released for distribution.No issues were identified that would have impacted this event.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.During vascular closure, hypotension was noted despite medication administration.Echocardiogram revealed a mild pericardial effusion which worsened over the course of ten minutes.Hypotension is a known potential adverse effect per instructions for use (ifu).It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.Pericardial effusion is also a known effect that can occur after cardiac procedures.A conclusive cause of the hypotension and effusion could not be determined from the limited information available.In this case, a pericardiocentesis was performed and hemodynamics stabilized with no further blood loss.It was suspected that an annular tear or perforation caused the bleeding.Per the physician, it was thought that the perforation was caused by the post-implant bav.This event did not indicate device misuse or malfunction.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, a balloon aortic valvuloplasty (bav) was performed.The valve was deployed successfully on the first attempt.Aortography revealed evidence that the valve did not fully expand and echocardiogram indicated mild to moderate paravalvular leak (pvl).A post-implant bav was performed using a 24 mm non-medtronic balloon.Following bav, pvl had reduced to trivial and it was noted that the valve had expanded.During vascular closure, hypotension was noted despite medication administration.Echocardiogram revealed a mild pericardial effusion which worsened over the course of ten minutes.A pericardiocentesis was performed and hemodynamics stabilized with no further blood loss.It was suspected that an annular tear or perforation caused the bleeding.Per the physician, it was thought that the perforation was caused by the post-implant bav.No additional adverse patient effects were reported.

• 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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10791200
• MDR Text Key: 214746764
• Report Number: 2025587-2020-03438
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2020

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: 10/31/2021
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/05/2020
• Date Device Manufactured: 01/03/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 76 YR