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

Model Number 638BL

Device Problem Incomplete Coaptation (2507)

Patient Problems Erosion (1750); Endocarditis (1834); Mitral Insufficiency (1963); Mitral Regurgitation (1964); Mitral Valve Prolapse (2471)

Event Date 10/03/2017

Event Type  Injury  

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 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
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6999815
• MDR Text Key: 90984560
• Report Number: 2025587-2017-02010
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994758811
• UDI-Public: 00613994758811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: 638BL
• Device Catalogue Number: 638BL32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR