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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 800
Device Problem Split
Event Date 11/14/2016
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. The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution. No issues were identified that would have impacted this event.

 
Event Description

Medtronic received information that this annuloplasty ring was implanted in the mitral position, and subsequently explanted during the same procedure after a tear in the patient's native valve was discovered. Following implant, the valve was re-inspected and was found to be torn at the annular level. It was noticed that the valve was undersized with the 26mm ring. There was moderate mitral insufficiency and very eccentric jet following implant. The ring was then explanted and replaced by a bioprosthetic mitral valve. 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)
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 Key6264667
Report Number2025587-2017-00118
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
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 Received01/19/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/30/2014
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: 01/19/2017 Patient Sequence Number: 1
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