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

Model Number	995MS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the device remains implanted.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.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 4 years and 3 months post implant of this bioprosthetic valve, it was replaced valve-in-valve due to aortic insufficiency and stenosis.No other adverse patient effects were reported.
Additional Manufacturer Narrative
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.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 6503786
• Report Number: 2025587-2017-00612
• Device Sequence Number: 10766714
• Product Code: LWR
• UDI-Device Identifier: 00643169002036
• UDI-Public: 00643169002036
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2017

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: 07/01/2017
• Device Model Number: 995MS
• Device Catalogue Number: 995MS25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 39 YR
• Patient Weight: 66