MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number D-EVPROP2329US

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

Patient Problems Intimal Dissection (1333); Death (1802); Blood Loss (2597)

Event Date 07/14/2020

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, while advancing the delivery catheter system (dcs), an aortic dissection occurred.It was noted that the patient had a tight bend in the abdominal aorta with tortuosity and calcium.The dcs and valve were withdrawn from the patient, and the dissection was treated with a 27x95 endokogix covered stent graft.Per the physician, the cause of the aortic dissection was believed to be a combination of patient anatomy and the attempts made to deliver the system.A new valve and dcs were used to complete the procedure.One day after the valve implant, the patient died.The death, due to bleeding, was reported to be a result of endoleak post stent graft repair of the aortic dissection.It was speculated that the endoleak was a type one leak due to the sealing of the graft.An autopsy was not performed.

• Brand Name: EVOLUT PRO PLUS DCS
• 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: 10338704
• MDR Text Key: 200812213
• Report Number: 2025587-2020-02368
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2020

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: 03/01/2021
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010157414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/29/2020
• Date Device Manufactured: 03/01/2020
• 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): Death; Required Intervention