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

Model Number EVOLUTR-23

Device Problem Malposition of Device (2616)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Non specific EKG/ECG Changes (1817)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

Citation: ojeda s et al.Impact of the repositionable evolut r corevalve system on the need for a permanent pacemaker after transcatheter aortic valve implantation in patients with severe aortic stenosis.Catheter cardiovasc interv.2019 may 7.Doi: 10.1002/ccd.28327.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; 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 literature regarding a comparison of the incidence for permanent pacemaker implantation in patients who underwent transcatheter aortic valve implantation (tavi) with the corevalve or evolut r.All data was collected between april 2008 and february 2018.The study population included 345 patients and was predominantly female with a mean age of 79 years.All patients were implanted with medtronic transcatheter bioprosthetic valves: corevalve (208) or evolut r (137).No serial numbers were provided.Among all patients, it was reported that 9 early deaths occurred.No other details were provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: post-tavi permanent pacemaker implantation (55 cases occurred during the index hospital ization, 5 cases occurred between hospital discharge and one-month post-implant, and 9 cases occurred after one-month post-implant).The indications for permanent pacemaker implantation were: greater atrioventricular block, symptomatic bradycardia, sinus node dysfunction, and symptomatic combination of a right bundle branch block, left anterior or posterior fascicular block, and a first-degree atrioventricular block.New-onset left bundle branch block was observed with and without the need for permanent pacemaker implantation.Other adverse events observed: valve implanted low or high in the left ventricular outflow tract.Based on the available information, medtronic product was directly associated with the adverse events.No additional adverse 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: 9533212
• MDR Text Key: 182589460
• Report Number: 2025587-2019-03923
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/30/2019

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 Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/30/2019
• 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): Required Intervention
• Patient Age: 79 YR