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

Model Number	FR995-19
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/15/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: 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 or Problem Description
Medtronic received information that 4 years and 10 months post implant of this bioprosthetic valve implanted in the pulmonary position of a pediatric patient, a transcatheter pulmonary valve (tpv) was implanted valve-in-valve.The reason for valve replacement was not reported.No additional adverse patient effects were reported. .

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8969280
• Report Number: 2025587-2019-02746
• Device Sequence Number: 2510478
• Product Code: LWR
• UDI-Device Identifier: 10681490265888
• UDI-Public: 10681490265888
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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: 08/15/2012
• Device Model Number: FR995-19
• Device Catalogue Number: FR995-19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/06/2019
• 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: Required Intervention
• Patient Age: 8 YR