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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 Incomplete Coaptation
Event Date 02/23/2017
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen was discarded by the user facility. Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation. Should additional information become available, a supplemental report will be submitted. 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 information that after implant of this annuloplasty ring, the physician was not satisfied with the coaptation of the native tissue. The physician explanted the device during the same procedure and implanted a non-medtronic device. No further 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 Key6388810
Report Number2025587-2017-00371
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/01/2018
Device MODEL Number800
Device Catalogue Number800SR24
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 Received02/23/2017
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: 03/08/2017 Patient Sequence Number: 1
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