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

Model Number 40019

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/21/2018

Event Type  Death  

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 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.

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.

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
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES 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: 8174623
• MDR Text Key: 130672643
• Report Number: 2025587-2018-03455
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983175
• UDI-Public: 00643169983175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170006
• 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,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2019
• Device Model Number: 40019
• Device Catalogue Number: 40019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Date Device Manufactured: 05/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 70 YR