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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING RING, ANNULOPLASTY Back to Search Results
Model Number 620R
Device Problems Gradient Increase (1270); Device Appears to Trigger Rejection (1524); Obstruction of Flow (2423)
Patient Problems Host-Tissue Reaction (1297); Dyspnea (1816); Mitral Valve Stenosis (1965)
Event Date 10/19/2005
Event Type  Injury  
Manufacturer Narrative

Citation: bisoi ak et al. Mitral stenosis after duran ring annuloplasty for non-rheumatic mitral regurgitation--a foreign body response? heart lung circ. 2006 jun;15(3):189-90. Doi: 10. 1016/j. Hlc. 2005. 08. 005. Epub 2005 oct 19. Earliest date of publish used for event date in b3. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information via literature regarding a (b)(6) male patient with a history of myxomatous mitral regurgitation who had undergone mitral valve repair with a 27 mm medtronic duran ancore annuloplasty ring (serial number not provided). At 18 months post-mitral valve repair, the patient presented with dyspnea (new york heart association functional classification iii) and the results of a physical examination were consistent with severe mitral stenosis. The patient¿s mean and end diastolic gradients were noted to be 14 mmhg and 12 mmhg, respectively. Echocardiography showed enlarged left atrium without clots. Subsequently, the duran ancore ring was explanted. During explantation, pannus overgrowth onto the ring was observed. It was reported that histopathological analysis of the ring revealed foreign body giant cell reactions with a neo-myocardial patch surrounding the ring. No additional adverse patient effects or product performance issues were reported.

 
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Brand NameDURAN ANCORE RING
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 Key9355878
MDR Text Key173670759
Report Number2025587-2019-03547
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeIN
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
Report Date 11/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number620R
Device Catalogue Number620R
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 Received10/28/2019
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: 11/21/2019 Patient Sequence Number: 1
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