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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 Patient Device Interaction Problem
Event Date 12/21/2018
Event Type  Injury  
Manufacturer Narrative

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 11 years and 1 month post implant of this 29mm mitral annuloplasty ring, it was explanted and replaced with a non-medtronic mechanical valve. The reason for replacement was reported as severe mitral stenosis. It was also noted there was pannus overgrowth on the patient's native mitral valve. 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 Key9192103
Report Number2025587-2019-03143
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/16/2012
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 Received09/30/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 10/15/2019 Patient Sequence Number: 1
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