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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 638RL30
Device Problem Incomplete Coaptation
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative

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 immediately following the implant of this annuloplasty ring, the ring was explanted and replaced with a non-medtronic bioprosthetic valve. After implant of the ring, residual regurgitation was present and a posterior leaflet was recessed and retracted. Coaptation was improved but was not sufficient, therefore the mitral valve was fully replaced. 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 Key7635549
Report Number2025587-2018-01572
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number638RL30
Device Catalogue Number638RL30
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 Received06/04/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/13/2018
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: 06/25/2018 Patient Sequence Number: 1
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