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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG35 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION RING 620RG35 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY Back to Search Results
Model Number 620RG35
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 03/08/2018
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 immediately post implant of this 35 mm mitral annuloplasty ring, the ring was explanted and replaced with an unknown device.The reason for replacement was not reported.No additional adverse patient effects were reported. .
 
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Brand Name
RING 620RG35 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 Key7389792
Report Number2025587-2018-00754
Device Sequence Number1340172
Product Code KRH
UDI-Device Identifier00613994759023
UDI-Public00613994759023
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K032810
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/02/2018
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 Date07/20/2021
Device Model Number620RG35
Device Catalogue Number620RG35
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/15/2018
Initial Report FDA Received Date04/02/2018
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 Age75 YR
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