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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 Problems Inadequacy of Device Shape and/or Size; Insufficient Information
Event Date 03/27/2017
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. 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 this bioprosthetic valve was explanted immediately post implant. No failure mechanism and no other adverse patient effects were reported.

 
Manufacturer Narrative

Medtronic received additional information that this annuloplasty ring was replaced because it was too small. The device was explanted and replaced with a larger ring. There were no complications due to the replacement procedure. Please note: the event description for this event originally reported it as a "bioprosthetic valve. " it is not a bioprosthetic valve, but an annuloplasty ring, and a non-tissue 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.

 
Manufacturer Narrative

Correction: implanted and explanted dates have been added to section d. Suspect medical 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.

 
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 Key6503713
Report Number2025587-2017-00610
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number800
Device Catalogue Number800SR40
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 Received05/09/2017
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

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