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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING, ANNULOPLASTY Back to Search Results
Model Number H608H
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Heart Failure (2206)
Event Date 01/14/2016
Event Type  Injury  
Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation. (b)(4).

 
Event Description

Medtronic received information that 16 years 10 months post implant of this mitral annuloplasty ring, the patient presented with persistent hypotension and acute chronic congestive heart failure with worsening symptoms including shortness of breath and fatigue. A transesophageal echocardiogram (tee) showed severe mitral stenosis and severe mitral insufficiency. The physician stated that the annuloplasty ring appeared to be overly small, and the regurgitation appeared to be due to tethering of the posterior and anterior leaflets. The physician explanted the device, performed a debridement of the mitral valve from an investing scar, and implanted a 27mm annuloplasty band. No evidence of mitral regurgitation or mitral stenosis was observed post implant. No further adverse patient effects were reported.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

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Brand NameDURAN ANCORE
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key5463126
MDR Text Key39117528
Report Number2025587-2016-00238
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/02/2004
Device MODEL NumberH608H
Device Catalogue NumberH608H29
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 Received04/22/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/02/1999
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: 02/26/2016 Patient Sequence Number: 1
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