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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 638RL32
Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
Patient Problems Mitral Regurgitation (1964); No Information (3190)
Event Date 04/02/2018
Event Type  Injury  
Manufacturer Narrative

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 during the implant of this annuloplasty ring, the ring was explanted and replaced. The reason for explant was not reported. No additional adverse patient effects were reported.

 
Manufacturer Narrative

Medtronic received additional information that after the 32mm ring was implanted and tested moderate regurgitation was still present. The surgeon replaced the ring with a 38mm ring, stating the fit was better. 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 Key7469336
MDR Text Key106772598
Report Number2025587-2018-01006
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
Report Date 05/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number638RL32
Device Catalogue Number638RL32
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 Received05/11/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/14/2017
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: 04/27/2018 Patient Sequence Number: 1
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