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

Model Number EVOLUTR-23

Device Problems Backflow (1064); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problems Aortic Valve Stenosis (1717); Cusp Tear (2656); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Citation: yang b., et al.A y incision and rectangular patch to enlarge the aortic annulus by three valve sizes.The annals of thoracic surgery, august 2021; 112(2):e139-e141.Doi.Org/10.1016/j.Athoracsur.2021.01.072.Published: march 05, 2021.Earliest date of publish used for date of event.Medtronic products referenced: corevalve evolut (pma# p130021, product code: npt).Earliest approved product used for product code and pma#.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 (b)(6) female patient (92 kg weight) with a history of multiple cardiac surgery, including aortic valve replacement (avr) using a non-medtronic valve along with a valve-in-valve transcatheter avr using a 23-mm medtronic corevalve evolut bioprosthetic valve.The patient was hospitalized with congestive heart failure due to severe aortic mixed stenosis/insufficiency.She underwent aortic root re-enlargement surgery, debridement with valve removal and implantation of a non-medtronic mechanical aortic valve.The patient was later discharged from the hospital without complications.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

A supplemental report is being submitted for additional information.B5, g3, h6.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the physician/author noted that a cusp fracture in the medtronic evolut r bioprosthetic valve caused the adverse event, which required valve replacement.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12763848
• MDR Text Key: 280467866
• Report Number: 2025587-2021-03368
• Device Sequence Number: 1
• Product Code: NPT
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 23-MM MAGNA EASE AORTIC VALVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 95 KG