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

Model Number EVOLUTPRO-29-US

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

Patient Problems Cardiac Arrest (1762); Death (1802); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 12/05/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Product analysis: the product was discarded by the customer; therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn 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, at 80% deployment, hypotension was noted.Medication was administered.Hypertension was noted and electrocardiogram (ecg) indicated asystole.The system was removed and cardiopulmonary resuscitation (cpr) was initiated.Pulmonary bleeding was suspected as bleeding from the mouth was noted.Thirty minutes of cpr was performed, and blood pressure and heart rate recovered.A valve was not implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was received: it was suspected that the pulmonary bleeding occurred due to hypertension.Per the physician, there was no evidence to suggest that the valve caused or contributed to the pulmonary bleeding.One day after the procedure, the patient expired.The cause of death was pulmonary hemorrhage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVOLUT PRO 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: 8203633
• MDR Text Key: 131636409
• Report Number: 2025587-2018-03577
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000017835
• UDI-Public: 00763000017835
• 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,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: EVOLUTPRO-29-US
• Device Catalogue Number: EVOLUTPRO-29-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• Date Device Manufactured: 07/23/2018
• 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
• Patient Age: 89 YR
• Patient Weight: 70