MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION MOSAIC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305U

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

Patient Problem Aortic Regurgitation (1716)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

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 Description

Medtronic received information that 11 years and 5 months post implant of this bioprosthetic valve, a transcatheter valve was implanted valve-in-valve due to insufficiency of the bioprosthetic valve.No additional adverse patient effects were reported.

• Brand Name: MOSAIC
• 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: 7109535
• MDR Text Key: 94553065
• Report Number: 2025587-2017-02418
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00885074253244
• UDI-Public: 00885074253244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• 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: 12/12/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2011
• Device Model Number: 305U
• Device Catalogue Number: 305U23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/12/2017
• Date Device Manufactured: 03/16/2006
• 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): Required Intervention
• Patient Age: 79 YR