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

Model Number	FR995
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Information (3190)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If additional information if received a supplemental report will be sent.
Event or Problem Description
Medtronic received information that approximately four years and nine months post implant of this bioprosthetic valve, the valve was replaced valve-in-valve with a medtronic transcatheter valve for unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Additional information was received indicating that the bioprosthetic valve was replaced due to calcification.No further adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information was received with the patient weight.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: 6970418
• Report Number: 2025587-2017-01903
• Device Sequence Number: 18855393
• Product Code: LWR
• UDI-Device Identifier: 00643169002098
• UDI-Public: 00643169002098
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/30/2017

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: 06/21/2017
• Device Model Number: FR995
• Device Catalogue Number: FR995-19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 10/30/2017; 10/30/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 10/30/2017; 10/30/2017
• 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: 9 YR
• Patient Weight: 52