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

Model Number EVOLUTR-26

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Loss Of Pulse (2562); Vascular System (Circulation), Impaired (2572)

Event Date 10/15/2020

Event Type  Death  

Manufacturer Narrative

Citation: balbi m, pllaha e, cassar a, maempel a, xuereb rg from mater dei hospital in msida, malta.Self-expanding tavi device, when higher may not be better.Acc world congress of cardiology tct connect 2020 video presentation on october 15, 2020.This content was not known to have been published to date.The embedded video could not be downloaded.Hyperlink to video content: https://www.Tctconnect.Com/science-abstracts-challenging-cases-detail/?aid=28044.Date of presentation used for event date in and death date in; 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 via a medical conference video presentation on a case regarding a (b)(6) year old female patient who underwent transcatheter aortic valve implantation (tavi) of a medtronic evolut r bioprosthetic valve (no serial numbers provided).During the procedure, upon successful valve deployment, an angiography showed a high valve position with wide patency of both the left and right coronary arteries.Approximately 30 minutes post-procedure the patient became hypotensive with diffuse st segment elevation.Further imaging excluded cardiac tamponade and iliac vascular complications.An aortogram showed the bioprosthetic valve had migrated upwards from the original implant site and had obstructed the left coronary artery in part and the right coronary artery completely.The left coronary artery was successfully cannulated to return appropriate blood flow, however the right coronary artery could not be cannulated.Subsequently, the patient then went into ventricular fibrillation, tachycardia, and cardiac arrest.Several external shocks were delivered with a temporary return of spontaneous circulation, however the patient eventually deteriorated into pulseless electrical activity.Cardiopulmonary resuscitation (cpr) was initiated with a lucas chest compression system.Additionally, the valve was snared and pulled upwards to successfully eliminate obstruction of both coronary artery ostia.Unfortunately, despite these interventions the patient continued to deteriorate and died of a cardiac arrest.In retrospect, the physicians suspected the self-expanding bioprosthetic valve may have forced the native valve leaflets to block both coronary ostia.No additional adve rse patient effects or product performance issues 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: 10723460
• MDR Text Key: 212684976
• Report Number: 2025587-2020-03205
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: MT
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-26
• Device Catalogue Number: EVOLUTR-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 78 YR