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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND RING, ANNULOPLASTY Back to Search Results
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.

 
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Brand NameCG FUTURE BAND
Type of DeviceRING, 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 Key6999815
MDR Text Key90984560
Report Number2025587-2017-02010
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK011395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received11/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number638BL
Device Catalogue Number638BL32
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/22/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/03/2017 Patient Sequence Number: 1
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