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

Model Number	305U2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: a review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.From the limited information received the valve remained implanted.Without the return of the valve for analysis, a root cause of the stenosis cannot be de termineted.The common probable cause for stenosis is pannus overgrowth.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 7 years 3 months post implant of this aortic bioprosthetic valve, the device was replaced valve-in-valve with a transcatheter valve due to aortic stenosis.No other adverse patient effects were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART 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: 6823676
• Report Number: 2025587-2017-01482
• Device Sequence Number: 16521876
• Product Code: LWR
• UDI-Device Identifier: 00613994479235
• UDI-Public: 00613994479235
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2015
• Device Model Number: 305U2
• Device Catalogue Number: 305U225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/28/2017
• 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: Required Intervention
• Patient Age: 86 YR