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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEART VALVES SANTA ANA SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY

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HEART VALVES SANTA ANA SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 800
Device Problem Incomplete Coaptation (2507)
Patient Problems Failure of Implant (1924); Mitral Regurgitation (1964)
Event Date 10/06/2016
Event Type  Injury  
Manufacturer Narrative

The device has not been received for analysis. Without the receipt 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 immediately post implant of this annuloplasty ring in the mitral position, this ring was explanted and replaced with a bioprosthetic valve due to excessive regurgitation of the patient's native valve, and posterior leaflet flail. The physician reported that the patient's "native mitral annulus was small," and they were "unable to achieve a satisfactory repair" using several different techniques. Following implant of this ring and synthetic mitral valve chordae, the "valve was a bit more competent, but there was very little plane of coaptation. The anterior leaflet was completely extended. " following placement of additional synthetic mitral valve chordae, "the valve was not sufficiently competent. And the annuloplasty ring began to separate from the anterior portion of the annulus. " at this point, mitral valve repair was abandoned and a bioprosthetic mitral valve was implanted. No other adverse patient effects were reported.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameSIMULUS SEMI-RIGID ANNULOPASTY RING
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key6055640
MDR Text Key58353104
Report Number2025587-2016-01672
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072655
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 10/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number800
Device Catalogue Number800SR26
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 Received10/06/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/31/2016
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: 10/25/2016 Patient Sequence Number: 1
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