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

Model Number EVOLUTR-29-C

Device Problems Material Invagination (1336); Patient Device Interaction Problem (4001)

Patient Problems Non specific EKG/ECG Changes (1817); Obstruction/Occlusion (2422); Hypervolemia (2664); Thrombocytopenia (4431)

Event Date 06/02/2017

Event Type  Injury  

Event Description

Medtronic received information that one day following the implant of this transcatheter bioprosthetic valve, an electrocardiogram revealed left bundle branch block and no treatment was prescribed.No adverse patient effects were reported.Additional information was received that two days following valve implant, thrombocytopenia and fluid overload were noted.The throm bocytopenia was reported to be "possibly secondary to platelet activation triggered by new valve".The patient was treated with medications in the drug classifications of platelet inhibitors, non-steroidal anti-inflammatory, and diuretic.On the fifth post-operative day, the fluid overload was resolved.Nearly three months after the valve implant procedure, when the operative report was reviewed, a "potential" infold was noted in the valve frame during the valve implant procedure and, a "potential" left ventricular outflow tract obstruction was noted three days following valve implant; however, neither were confirmed.No further information was reported.No adverse patient effects were reported.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) related to capa pr 564122.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18946628
• MDR Text Key: 338186650
• Report Number: 2025587-2024-01796
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Model Number: EVOLUTR-29-C
• Device Catalogue Number: EVOLUTR-29-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Date Device Manufactured: 04/07/2017
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 76 KG