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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 24MM RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 24MM RING, ANNULOPLASTY Back to Search Results
Model Number 680R
Device Problems Gradient Increase; Inadequacy of Device Shape and/or Size; Insufficient Information
Event Date 06/21/2017
Event Type  Injury  
Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that 1 year 2 months post implant of this mitral annuloplasty ring, the device was explanted and replaced with a bioprosthetic valve for unknown reasons. No other adverse patient effects were reported.

 
Manufacturer Narrative

Additional information received indicated that the device was explanted due to symptomatic mitral stenosis, residual regurgitation, and elevated gradients. The physician stated that the ring was probably too small for the patient, and this, combined with underlying subvalvular fibrosis, led to the stenosis. No additional adverse patient effects were reported.  added patient weight; added patient device codes. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameRING PROFILE 3D 24MM
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 Key6770935
Report Number2025587-2017-01317
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number680R
Device Catalogue Number680R24
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 Received08/18/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/22/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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