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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEART VALVES SANTA ANA CG FUTURE BAND; RING, ANNULOPLASTY
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HEART VALVES SANTA ANA CG FUTURE BAND; RING, ANNULOPLASTY Back to Search Results
Model Number 638RL
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/09/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that this mitral annuloplasty ring was implanted and explanted during the same procedure.The device was explanted and replaced with a bioprosthetic valve due to a failure of the patient's native tissue.No other adverse patient effects were reported.
 
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Brand Name
CG FUTURE BAND
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
MDR Report Key6730518
Report Number2025587-2017-01211
Device Sequence Number932157
Product Code KRH
UDI-Device Identifier00613994758736
UDI-Public00613994758736
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K061127
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/29/2017
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 Date08/31/2020
Device Model Number638RL
Device Catalogue Number638RL38
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/29/2017
Initial Report FDA Received Date07/20/2017
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;
Patient Age63 YR
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