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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 (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2015
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen will not be returned for evaluation, as it was disposed of by the medical institution. Conclusion: attempts to obtain patient weight were made; however, these attempts were unsuccessful. Without return of the product, no definitive conclusions could be drawn regarding the clinical observation. Should additional information become available, a supplemental report will be submitted. (b)(4).

 
Event Description

Medtronic received information that 1 year 1 month post implant of this 28mm mitral annuloplasty ring, the device was explanted and replaced with a 23mm annuloplasty band. The physician determined that the valve wasn't functioning properly because the device was the incorrect size. No further adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: reoperations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions. Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair. In this case, the event appears to be related to sizing error.

 
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 STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key5442064
MDR Text Key38377860
Report Number2025587-2016-00194
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2019
Device MODEL Number638R
Device Catalogue Number638RL28
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 Received03/02/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/14/2014
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: 02/17/2016 Patient Sequence Number: 1
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