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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING 620RG31 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY

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MEDTRONIC HEART VALVE DIVISION RING 620RG31 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY Back to Search Results
Model Number 620RG31
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 07/10/2020
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 1 year and 2 months post implant of this 31mm mitral annuloplasty ring, it was explanted and replaced with a 27mm mitral bioprosthetic valve. The reason for the replacement was not reported.  no additional adverse patient effects were reported.

 
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Brand NameRING 620RG31 DURAN ANCORE ANNULOPLASTY C
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVE 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 Key10337633
MDR Text Key200769900
Report Number2025587-2020-02367
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,Followup
Report Date 09/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number620RG31
Device Catalogue Number620RG31
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 Received09/23/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/08/2018
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: 07/29/2020 Patient Sequence Number: 1
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