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

Model Number FR995-23

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Pseudoaneurysm (2605); Cusp Tear (2656); No Information (3190)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

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 10 years and 3 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a valve of the same size and model.The reason for replacement is unknown.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that 10 years and 3 months post implant of this 23mm aortic bioprosthetic valve, the patient presented with chest pain and shortness of breath.One week later, the patient underwent a computed tomography angiogram, which showed disruption of the proximal suture line between the implanted aortic valve and ascending aortic graft as well as a large pseudoaneurysm.Four days later, the aortic valve was explanted, a portion of the aortic graft was removed, and the hematoma/clot from the pseudoaneurysm was evacuated.The valve was noted to be dehisced from the ascending aortic graft, with a ¿couple¿ of millimeters of remaining connection near the left main coronary button.The explanted valve had multiple perforations noted on the non-coronary sinuses.A valve of the same size and model as the original valve was implanted, along with a non-medtronic vascular graft.No additional adverse patient effects were reported.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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7906147
• MDR Text Key: 121605526
• Report Number: 2025587-2018-02513
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490265904
• UDI-Public: 00681490265904
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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 Expiration Date: 02/26/2013
• Device Model Number: FR995-23
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 10/19/2018
• Date Device Manufactured: 03/12/2008
• 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: 76 YR