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

Model Number EVOLUTR-26

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Fever (1858); Low Blood Pressure/ Hypotension (1914); Ventricular Tachycardia (2132); Weakness (2145)

Event Date 04/02/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: no product was returned.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 during the implant of this transcatheter bioprosthetic valve, it was difficult to restore the patient's blood pressure following the pre-implant balloon aortic valvuloplasty (bav).Prior to the implant, the patient had hypocardiac function with an ejection fraction of 30-39%.Ventricular tachycardia occurred twice during the procedure and age-related macular degeneration (amd) was administered and external shock (dc) were performed.After the pressure increased, the delivery catheter system (dcs) was advanced passed the aortic valve, however when crossing, the patient's blood pressure decreased again.The valve was deployed to two thirds, however the patient's pressure did not recover.The valve was recaptured so percutaneous cardiopulmonary support (pcps) could be used.The blood pressure became stable and the valve implant was completed.The patient was attempted to be removed from pcps, however the blood pressure dropped so an intra-aortic balloon pumping (iabp) was used.The patient was transferred to the intensive care unit (icu).Three days following the valve implant, the ibap was removed.Twenty two days following the valve implant the cardiopulmonary arrest occurred and resuscitation efforts were performed.Twenty three days following the valve implant, the patient died.The cause of death was unknown.It was reported that the patient had general weakness due to low cardiac function, an unknown fever and possibility that the cause may have been from aspiration and choking of the feeding tube.It is unknown whether an autopsy was performed.

• 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: 10091899
• MDR Text Key: 192169446
• Report Number: 2025587-2020-01716
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• 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: 05/18/2020
• Date Device Manufactured: 11/15/2019
• 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): Death
• Patient Age: 93 YR