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

Model Number	995CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Multiple Organ Dysfunction Syndrome (3261)
Date of Event	03/01/2018
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.Other relevant device(s) are: product id: 305u229, serial/lot #: (b)(4), ubd: 10-jan-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that two days post implant of these bioprosthetic valves, the patient died.The cause of death was reported as multi-organ failure.There was no allegation that the valves contributed to the patient's death.It is unknown if an autopsy was performed or if the devices were explanted.

• 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: 7464000
• Report Number: 2025587-2018-00985
• Device Sequence Number: 13882184
• Product Code: LWR
• UDI-Device Identifier: 00643169002302
• UDI-Public: 00643169002302
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/26/2018

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: 10/18/2021
• Device Model Number: 995CS
• Device Catalogue Number: 995CS27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/26/2018
• 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
• Patient Age: 56 YR