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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG29 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION RING 620RG29 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY Back to Search Results
Model Number 620RG29
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Rupture (2208)
Date of Event 11/28/2017
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 immediately post implant of this annuloplasty ring, the ring was explanted and replaced with a non-medtronic valve due to rupture of the patient's mitral cords.No adverse patient effects were reported.
 
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Brand Name
RING 620RG29 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 Key7141893
Report Number2025587-2017-02538
Device Sequence Number11049003
Product Code KRH
UDI-Device Identifier00613994758965
UDI-Public00613994758965
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K960356
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) 12/22/2017
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 Date12/18/2018
Device Model Number620RG29
Device Catalogue Number620RG29
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2017
Initial Report FDA Received Date12/22/2017
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 Age68 YR
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