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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 638B
Device Problems Incomplete Coaptation; Insufficient Information
Event Date 01/25/2017
Event Type  Injury  
Manufacturer Narrative

Additional information has been requested, but no new information has been received. The device has not been received for analysis. Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that 5 years and 11 months post implant of this annuloplasty band in the mitral position, it was explanted and replaced with a bioprosthetic valve. No failure mechanism was provided. No other adverse patient effects were reported.

 
Manufacturer Narrative

Additional information was received indicating that this annuloplasty band was explanted and replaced due to severe mitral regurgitation, secondary to posterior leaflet restriction and anterior leaflet coaptation failure. This patient was symptomatic with dyspnea and elevated pulmonary pressures. No other adverse patient effects were reported. This product is not available for return.

 
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
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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 Key6354959
Report Number2025587-2017-00309
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2015
Device MODEL Number638B
Device Catalogue Number638BL28
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 Received02/08/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/2010
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: 02/23/2017 Patient Sequence Number: 1
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