MAUDE Adverse Event Report: HEART VALVES SANTA ANA CG FUTURE RING; RING, ANNULOPLASTY

Model Number	638RL30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information was received on february 23, 2021 from follow-up with the physician/author of the literature summarized in mdr# 2025587-2021-00570.Literature citation: mayr et al.Mitral valve repair in children below age 10 years: trouble or success? ann thorac surg.2020 dec; 110(6):2082-2087.Doi: 10.1016/j.Athoracsur.2020.02.057.Epub 2020 mar 30.Earliest date of publish used for date of event.A review of the medtronic global complaint handling database with the provided unique device identifier numbers found no previous records.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that two days after implant of a 30-mm colvin-galloway future ring (serial (b)(4)) significant mitral regurgitation was observed.Per the physician/author, during a mitral valve replacement procedure the implanted ring was noted as having no pathologic alterations.

• Brand Name: CG FUTURE RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11396953
• Report Number: 2025587-2021-00721
• Device Sequence Number: 3132320
• Product Code: KRH
• UDI-Device Identifier: 00613994521040
• UDI-Public: 00613994521040
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: 12/30/2014
• Device Model Number: 638RL30
• Device Catalogue Number: 638RL30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/01/2021
• 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: Congenital Anomaly; Life Threatening; Required Intervention