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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 638RL
Device Problem Inadequacy of Device Shape and/or Size
Event Date 03/28/2018
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 immediately post implant of this mitral annuloplasty ring, the ring was explanted and replaced with an unknown device due to a "poor fit". No additional adverse patient effects were reported.  .

 
Manufacturer Narrative

Medtronic received additional information that immediately post implant of this mitral annuloplasty ring, transesophageal echocardiogram (tee) revealed severe mitral regurgitation so the physician decided to completely replace the native valve with a non-medtronic bioprosthetic valve. 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 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 Key7442995
Report Number2025587-2018-00915
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number638RL
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 Received05/30/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/11/2016
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: 04/19/2018 Patient Sequence Number: 1
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