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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY

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MEDTRONIC, INC. SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 800SR40
Device Problem Inadequacy of Device Shape and/or Size
Event Date 12/13/2016
Event Type  Injury  
Manufacturer Narrative

Analysis: the device has not been received for analysis. Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation. Conclusion: surgeons often attempt to repair mitral valves in lieu of replacing them due to improved long term clinical outcomes. There are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates an inadequate results. This is often due to suboptimal anatomy, surgical technique, or inappropriate sizing, and not a malfunction of the device. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received additional information from this physician that this device was implanted and explanted in the same procedure because the ring was too small. The device was replaced with another annuloplasty ring. There were no ring related problems, and 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, INC.
3800 annapolis lane
minneapolis MN 55447
Manufacturer (Section G)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view , MN 55112
7635055378
MDR Report Key6452031
Report Number3008592544-2017-00014
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number800SR40
Device Catalogue Number800
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 Received03/23/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/31/2015
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: 04/02/2017 Patient Sequence Number: 1
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