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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
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes High Blood Pressure/ Hypertension (1908); Rheumatic Heart Disease (2053)
Date of Event 11/17/2017
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Medtronic received information that following the implant of this annuloplasty ring, the physician noted that due to patient anatomy abnormality, the ring could not be implanted.No additional adverse patient effects were reported.
 
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Brand Name
CG FUTURE BAND
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7105697
Report Number2025587-2017-02400
Device Sequence Number1235328
Product Code KRH
UDI-Device Identifier00613994758675
UDI-Public00613994758675
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K011395
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date04/21/2019
Device Model Number638RL32
Device Catalogue Number638RL32
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/17/2017
Initial Report FDA Received Date12/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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