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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620R27 DURAN ANCORE ANNULOPLASTY 27 RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING 620R27 DURAN ANCORE ANNULOPLASTY 27 RING, ANNULOPLASTY Back to Search Results
Model Number 620R27
Device Problem Incomplete Coaptation (2507)
Patient Problems Host-Tissue Reaction (1297); Mitral Valve Stenosis (1965)
Event Date 03/01/2009
Event Type  Injury  
Manufacturer Narrative

Citation: yunoki j. J card surg 2009;24:143-145. Mitral valve stenosis caused by abnormal pannus extension over the prosthetic ring and leaflets after duran ring mitral annuloplasty date of publish used for event date. 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 of a (b)(6) year-old female patient with for non-rheumatic mitral regurgitation (mr) associated with a ruptured posterior leaflet chordae. She underwent a procedure with quadrangular resection, reconstruction of the posterior leaflet chordae, and implant of a 27-mm medtronic duran ring. Subsequently, five years and eight months (at the age of (b)(6) years) after the initial implant the patient presented with exertional dyspnea. Radiography showed mild cardiac enlargement. Electrocardiogram revealed sinus rhythm with left atrial overload. Cardiac catheterization showed pulmonary artery pressure of 60/35. During a sternotomy the mitral ring and both leaflets were found covered by pannus which narrowed the mitral orifice and restricted the leaflet mobility. The ring and both leaflets were resected. Histopathological examination showed foreign body granuloma associated with giant cells around the excised duran ring and leaflet thickening together with infiltration of inflammatory cells. 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 620R27 DURAN ANCORE ANNULOPLASTY 27
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 Key5887172
MDR Text Key52488558
Report Number2025587-2016-01282
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeJA
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 Received08/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number620R27
Device Catalogue Number620R27
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: 08/18/2016 Patient Sequence Number: 1
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