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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 638B
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2016
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen has not been returned to medtronic. Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation. Should the device be returned or additional information become available, a supplemental report will be submitted.

 
Event Description

Medtronic received information that this 36 mm annuloplasty ring was explanted and replaced almost immediately following implant because it demonstrated residual, mild regurgitation when tested; the physician opted to implant a smaller, 32 mm ring instead. No other adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: surgeons often attempt to repair valves in lieu of replacing them due to improved long term clinical outcomes. There are occurrences when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates an inadequate result. This may likely be due to suboptimal anatomy, surgical technique or inappropriate sizing and not a malfunction of the annuloplasty ring.

 
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 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 Key5680108
MDR Text Key45936339
Report Number2025587-2016-00769
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberD031411
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 06/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number638B
Device Catalogue Number638BL36
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 Received06/20/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/19/2016
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: 05/25/2016 Patient Sequence Number: 1
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