MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); No Information (3190)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

The available information indicates the device remains implanted.Additional information has been requested regarding the device's f unctionality, any adverse patient effects and the patient's weight.A supplemental report will be filed if additional information is received and/or when investigation is completed.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

Medtronic received information that eleven years, six months post-implant of this bioprosthetic aortic valve, this device was replaced valve-in-valve with a transcatheter bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this valve was replaced due to severe regurgitation with flail left bioprosthetic cusp.Prior to the replacement procedure, the patient presented with symptoms of dyspnea with exertion, progressively worsening shortness of breath, and congestive heart failure exasperation.The patient is doing well following the replacement procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 6693048
• MDR Text Key: 79271567
• Report Number: 2025587-2017-01112
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 10681490265918
• UDI-Public: 10681490265918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FR995
• Device Catalogue Number: FR99525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 36 YR
• Patient Weight: 70