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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 638R
Device Problem Inadequacy of Device Shape and/or Size
Event Date 09/03/2016
Event Type  Injury  
Manufacturer Narrative

The device has not been received for analysis. Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.

 
Event Description

Medtronic received information that after this annuloplasty ring was sutured into place, the patient's leaflets would not coapt properly. The physician determined that the device was the incorrect size for the patient. The device was explanted and replaced with a bioprosthetic valve during the same procedure. No further adverse patient effects were reported.

 
Manufacturer Narrative

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 Key6146801
Report Number2025587-2016-01923
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/14/2020
Device MODEL Number638R
Device Catalogue Number638RL30
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/28/2015
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: 12/06/2016 Patient Sequence Number: 1
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