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

Model Number EVOLUTR-34

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802); Embolism (1829); Ischemia (1942); Liver Damage/Dysfunction (1954)

Event Date 05/01/2020

Event Type  Death  

Manufacturer Narrative

Citation: mauri v et al.Impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement with different next-generation devices.Open heart.2020 may;7(1):e001164.Doi: 10.1136/openhrt-2019-001164.Earliest date of publish used for event date and death date.The literature article was previously reported via regulatory report # 2025587-2020-01879.A review of the medtronic global complaint handling database with the provided device identifier (serial number) returned no duplicate records.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 literature regarding the impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement (tavr).The study population included 642 patients (predominantly female, mean age 82 years), 132 of whom were implanted with medtronic evolut r bioprosthetic valve (no serial numbers provided).Among medtronic evolut r patients, seven deaths occurred within 30 days of implant.No further details were provided on these deaths.Based on the available information medtronic product was not directly associated with the death(s).Among medtronic evolut r patients adverse events included: mild to severe paravalvular leak (pvl), major vascular or bleeding complications, permanent pacemaker implant, and stroke.Based on the available information medtronic product was directly associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.Additional information received from the physician/author provided these details: case 2: following implant of the evolut r valve (serial (b)(4)) the patient had an embolic vertebrobasilar stroke, multiple lesions in liver and spleen, and severe brain stem ischemia.The patient died the same day as the procedure.No further details were provided regarding this patient or device.

• 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: 10203353
• MDR Text Key: 196675599
• Report Number: 2025587-2020-02048
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2018
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• Date Device Manufactured: 08/03/2017
• 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