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

Model Number 995

Device Problem Gradient Increase (1270)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Citation: mohamed marzouk, md article: ascending aortic replacement and sutureless valve in a failed stentless aortic prosthesis: a bailout option the annals of thoracic surgery 2016: 102(6):e507-e509 10.1016/j.Athoracsur.2016.05.024 earliest date of publish used for event date.No unique device identifier (serial numbers) were provided; without this information it could not be determined whether these observations have been previously reported.

Event Description

Medtronic received information via literature regarding a (b)(6) male patient with dyspnea 17 years after an aortic valve replacement with a 23-mm medtronic freestyle stentless bioprosthesis (serial number not provided).Echocardiography revealed severe aortic stenosis with a peak gradient of 85 mm hg and severe aortic insufficiency.The patient was not considered suitable for transcatheter aortic valve implant (tavi) and a non-medtronic valve was implanted.At replacement, there was a tear in the right coronary cusp of the freestyle prosthesis noted.No adverse patient effects were reported and the patient was discharged after 7 days.

Manufacturer Narrative

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

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 6151992
• MDR Text Key: 61649170
• Report Number: 2025587-2016-01947
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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 Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: 11/22/2016
• Supplement Dates FDA Received: 09/27/2017
• 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: 78 YR