MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638BL
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Erosion (1750); Endocarditis (1834); Mitral Insufficiency (1963); Mitral Regurgitation (1964); Mitral Valve Prolapse (2471)
Date of Event	10/03/2017
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 information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant procedure of this annuloplasty band, the band was explanted and replaced with a bioprosthetic valve.The surgeon reported that the patient had myxomatous mitral valve disease with flail posterior leaflet due to erosion of the primary chordae, severe mitral regurgitation, and previous alpha streptococcal endocarditis.During the procedure it was verified that there were no signs of active infection, thus the surgeon attempted to repair the valve.However, after coming off cardiopulmonary bypass (cpb), severe regurgitation was noted due to failure of the anterior leaflet coaptation from tethering of a1 and p1 leaflet segments.No additional adverse patient effects were reported.

• Brand Name: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6999815
• Report Number: 2025587-2017-02010
• Device Sequence Number: 1050933
• Product Code: KRH
• UDI-Device Identifier: 00613994758811
• UDI-Public: 00613994758811
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K011395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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: 06/21/2021
• Device Model Number: 638BL
• Device Catalogue Number: 638BL32
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 11/03/2017
• 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: 62 YR