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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 638BL34
Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
Patient Problems Mitral Regurgitation (1964); No Information (3190)
Event Date 09/04/2018
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 band, the band was explanted and replaced with an unknown device. The reason for the replacement was not reported. No additional adverse patient effects were reported.  .

 
Manufacturer Narrative

Medtronic received additional information from the physician that the 34mm band was implanted, tested, and removed due to "excessive regurgitation". It was reported the 34mm band was deemed to large and therefore replaced with a 28mm band of the same model. No additional adverse patient effects were reported. 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 Key7970478
MDR Text Key123867674
Report Number2025587-2018-02750
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052860
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number638BL34
Device Catalogue Number638BL34
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 Received10/29/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/08/2018
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: 10/16/2018 Patient Sequence Number: 1
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