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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 638BL26
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event 03/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: 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 immediately after the implant of this 26mm mitral annuloplasty band, significant residual regurgitation was present.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 Key11627998
Report Number2025587-2021-01075
Device Sequence Number4010500
Product Code KRH
UDI-Device Identifier00643169793583
UDI-Public00643169793583
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K052860
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/07/2021
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 Date07/10/2024
Device Model Number638BL26
Device Catalogue Number638BL26
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/23/2021
Initial Report FDA Received Date04/07/2021
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 Age64 YR
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