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

Model Number EVOLUTPRO-29

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

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

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted; therefore, no product analysis can be performed conclusion: conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or c atheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve).A conduction disturbance does not indicate a device malfunction or potential manuf acturing issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that at an unknown time following the implant of this transcatheter bioprosthetic valve, nonsustained ventricular tachycardia, first degree atrio-ventricular (av) block and complete left bundle branch block (lbbb) occurred.Subsequently, a permanent pacemaker was implanted 4 months and 25 days following the implant of the valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information reported that following the implant of this valve, left bundle branch block (lbbb) was reported on the day of the valve implant procedure.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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
• MDR Report Key: 8202859
• MDR Text Key: 131612964
• Report Number: 2025587-2018-03566
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2019

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 Expiration Date: 11/09/2018
• Device Model Number: EVOLUTPRO-29
• Device Catalogue Number: EVOLUTPRO-29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/25/2019; 02/05/2019
• Supplement Dates FDA Received: 01/29/2019; 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 78