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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING TRI-AD 900SFC32 RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING TRI-AD 900SFC32 RING, ANNULOPLASTY Back to Search Results
Model Number 900
Device Problems Inadequacy of Device Shape and/or Size; Insufficient Information
Event Date 03/07/2017
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen has not been returned for device analysis. Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful. 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.

 
Event Description

Medtronic received information that immediately post implant of this tricuspid annuloplasty ring, this device was explanted. No failure mechanism and no other adverse patient effects were reported.

 
Manufacturer Narrative

Medtronic received additional information that this device was replaced immediately post-implant because this annuloplasty ring did not have enough coverage to adequately downsize the valve annulus. There was residual moderate to severe tricuspid regurgitation following the device implant, so a different annuloplasty ring, was implanted with adequate results. There were no complications due to this replacement procedure.

 
Manufacturer Narrative

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

 
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Brand NameRING TRI-AD 900SFC32
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 Key6453674
Report Number2025587-2017-00519
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number900
Device Catalogue Number900SFC32
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 Received04/19/2017
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: 04/03/2017 Patient Sequence Number: 1
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