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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION RING 620RG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY Back to Search Results
Model Number 620RG31
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/24/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 approximately 10 months post implant of this 31mm tricuspid annuloplasty ring was explanted and replaced with a 29mm tricuspid bioprosthetic valve for unknown reasons.There were no additional adverse patient effects reported.
 
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Brand Name
RING 620RG31 DURAN ANCORE ANNULOPLASTY C
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key8117915
Report Number2025587-2018-03241
Device Sequence Number1569906
Product Code KRH
UDI-Device Identifier00613994758989
UDI-Public00613994758989
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K032810
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/29/2018
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 Date03/18/2020
Device Model Number620RG31
Device Catalogue Number620RG31
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/06/2018
Initial Report FDA Received Date11/29/2018
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 Age69 YR
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