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

Model Number	40019
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/21/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 40021, serial/lot #: (b)(4), udi#: 00643169983182, conclusion: without the return of the products, 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 immediately post implant of this 21mm aortic bioprosthetic valve, the valve was explanted and replaced with a 19mm valve of the same model for unknown reasons.One day post implant, the patient died.The cause of death was not received.There was no evidence to suggest that the valves or their function contributed to the patient¿s death.It is unknown whether an autopsy was performed.
Additional Manufacturer Narrative
Medtronic received additional information that immediately post implant of this 21mm aortic bioprosthetic valve, the valve was replaced valve-in-valve with a 19mm valve of the same model due to the valve potentially being oversized.One day post implant, the patient died.The cause of death was not received.There was no evidence to suggest that the valves or their function contributed to the patient¿s death.It is unknown whether an autopsy was performed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received additional information that immediately post implant of this 21mm aortic bioprosthetic valve, the valve was explanted and replaced with a 19mm valve of the same model due to the valve potentially being oversized.One day post implant, the patient died.The cause of death was not received.There was no evidence to suggest that the valves or their function contributed to the patient¿s death.It is unknown whether an autopsy was performed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8174623
• Report Number: 2025587-2018-03455
• Device Sequence Number: 16495446
• Product Code: LWR
• UDI-Device Identifier: 00643169983175
• UDI-Public: 00643169983175
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• 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,Followup,Followup
• Report Date (Section B): 01/28/2019

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: 11/07/2019
• Device Model Number: 40019
• Device Catalogue Number: 40019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/11/2019; 01/11/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/14/2019; 01/28/2019
• 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: 70 YR