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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVE DIVISION CG FUTURE BAND RING, ANNULOPLASTY Back to Search Results
Model Number 638RL28
Device Problem Incomplete Coaptation (2507)
Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)
Event Date 09/10/2018
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 eight years and eleven months post implant of this 28mm mitral annuloplasty ring, the ring was explanted and replaced with a 27mm bioprosthetic valve. The indication for replacement was severe regurgitation and moderate stenosis. Examination of the native mitral valve revealed thickened anterior and posterior leaflets. The posterior leaflet appeared retracted, and the surgeon felt this was contributing to the insufficiency. During the replacement procedure, a trapezoid portion of the anterior leaflet was resected, and the posterior leaflet was retained. Additionally, the native tricuspid valve was repaired with an annuloplasty ring. Post-operative transesophageal echocardiogram (tee) demonstrated mild mitral insufficiency and trivial tricuspid insufficiency. No additional interventions took place, and no additional adverse patient effects were reported.  .

 
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Brand NameCG FUTURE BAND
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVE 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 Key7943244
MDR Text Key123049062
Report Number2025587-2018-02674
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061127
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 10/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/24/2014
Device MODEL Number638RL28
Device Catalogue Number638RL28
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 Received09/18/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/27/2009
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: 10/08/2018 Patient Sequence Number: 1
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