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

Model Number 995CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Multiple Organ Failure (3261)

Event Date 03/01/2018

Event Type  Death  

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 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
• 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: 7464000
• MDR Text Key: 106587370
• Report Number: 2025587-2018-00985
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169002302
• UDI-Public: 00643169002302
• 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
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: 995CS
• Device Catalogue Number: 995CS27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Date Device Manufactured: 10/19/2016
• 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): Death
• Patient Age: 56 YR