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

Model Number	FR995
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Death (1802); Rupture (2208); Blood Loss (2597)
Date of Event	01/10/2018
Type of Reportable Event	Death
Additional 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 or Problem Description
Medtronic received information that 14 years and 7 months post implant of this 23mm aortic bioprosthetic valve, the valve was explanted and replaced with a 19mm valve of the same model. the reason for the explant was not reported.  no adverse patient effects were reported.Additional information was received that the reason for the valve replacement was that a computed tomography (ct) scan revealed an aortic rupture.Emergent surgery was performed and the 23mm valve was explanted and replaced with a 19mm valve of the same model.The physician reported that the patient was unable to be weaned off of cardiopulmonary bypass (cpb) and the stated cause of death was persistent bleeding.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7442576
• Report Number: 2025587-2018-00908
• Device Sequence Number: 13947303
• Product Code: LWR
• UDI-Device Identifier: 00643169002098
• UDI-Public: 00643169002098
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2018
• Device Model Number: FR995
• Device Catalogue Number: FR995-19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 56