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

Model Number EVPROPLUS-34US

Device Problems Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Cusp Tear (2656); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.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 /following the implant of this transcatheter bioprosthetic valve at 3 millimeter (mm), mild to moderate paravalvular leak (pvl) was observed.The physician decided to post implant balloon aortic valvuloplasty (bav) with a 28 mm non-medtronic balloon.The valve was ballooned twice due to recurring pvl.Transesophageal echocardiogram (tee) showed central aortic insufficiency(ai) in the valve.It appeared the leaflet my have been affected by the post implant bav.A second valve was implanted valve-in-valve and the central ai resolved.No additional adverse patient effects were reported. .

Manufacturer Narrative

Updated data: b5: updated event description: additional information was received that the moderate to severe aortic insufficiency of the valve was observed.There appeared to be a tear on the leaflet under transesophageal echocardiogram (tee).The post-implant balloon aortic valvuloplasty (bav) was inflated with a normal syringe however the inflation time and pressure were not recorded.No additional adverse patient effects were reported.  h6- updated patient and device codes corrected data: h8 - usage of device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: EVOLUT PRO PLUS 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: 11317271
• MDR Text Key: 231574601
• Report Number: 2025587-2021-00527
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211158
• UDI-Public: 00763000211158
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 94