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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Mitral Regurgitation (1964); No Information (3190)
Event Date 08/03/2020
Event Type  Injury  
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 Description

Medtronic received information that during the implant of this 29mm mitral annuloplasty ring, it was explanted and replaced with a non-medtronic device. The reason for the replacement was noted as "physician preference". No additional adverse patient effects were reported.

 
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Brand NameRING 620RG29 DURAN ANCORE ANNULOPLASTY C
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key10442297
MDR Text Key204014913
Report Number2025587-2020-02655
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number620RG29
Device Catalogue Number620RG29
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/31/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/24/2020 Patient Sequence Number: 1
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