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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 610R029 DURAN ANNULOPLASTY 29MM RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING 610R029 DURAN ANNULOPLASTY 29MM RING, ANNULOPLASTY Back to Search Results
Model Number 610R029
Device Problem Incomplete Coaptation (2507)
Patient Problems Host-Tissue Reaction (1297); Fatigue (1849); Mitral Valve Stenosis (1965)
Event Date 01/01/2002
Event Type  Injury  
Manufacturer Narrative

Citation: ibrahim, m et al. Mitral stenosis after mitral valve repair for non-rheumatic mitral regurgitation. Ann thorac surg. 2002;73:34¿6. No unique device identifier (serial/lot) numbers were provided; without this information, it could not be determined whether these observations have been previously reported.

 
Event Description

Medtronic received information via literature regarding mitral stenosis after mitral valve repair. All data were collected from two centers between january 1990 to december 1999. The study population included 518 patients, 152 of which were implanted with a medtronic duran ring (serial numbers not provided). Among all patients, four developed mitral stenosis late after valve repair. Patient 1 (pli 10): a (b)(6) year-old male underwent mitral valve repair with successful implant of a 29-mm duran ring. At 5 years and 5 months post-operative symptoms of fatigue and shortness of breath were noted. Echocardiography revealed mitral stenosis with a significantly decreased valve orifice. A reoperation was performed with implant of a 29-mm non-medtronic prosthetic mitral valve. Pathologic examination revealed no chordal fusion, shortening, or fibrosis, but the atrial side of the leaflets were thickened with signs of chronic inflammation that appeared to be originating from the annuloplasty ring. Etiology of the mitral stenosis was dense fibrous pannus overgrowth on the annuloplasty ring with extension onto both leaflets rendering them stiff and immobile and narrowing the valve orifice. No additional 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 NameRING 610R029 DURAN ANNULOPLASTY 29MM
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 Key5882544
MDR Text Key52319211
Report Number2025587-2016-01262
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK960356
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number610R029
Device Catalogue Number610R029
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 Received07/20/2016
Was Device Evaluated By Manufacturer? No
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: 08/17/2016 Patient Sequence Number: 1
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