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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND RING, ANNULOPLASTY Back to Search Results
Model Number 700FC27
Device Problem Inadequacy of Device Shape and/or Size
Event Date 12/18/2019
Event Type  Injury  
Manufacturer Narrative

Product analysis: no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that during the repair of the patient's native mitral valve due to severe regurgitation, the native valve was noted to have diminutive leaflets as well as leaflet perforation following what appeared to be healed endocarditis. The surgeon performed various suturing repairs to the mitral valve, but the valve still had regurgitation. Subsequently, this 27mm mitral annuloplasty band was implanted. It was reported that the regurgitation improved, however, residual regurgitation remained. As such the 27mm band was explanted and replaced with a 25mm band of the same model. No additional adverse patient effects were reported.

 
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Brand NameSIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
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 Key9691266
Report Number2025587-2020-00429
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number700FC27
Device Catalogue Number700FC27
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 Received01/16/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 02/11/2020 Patient Sequence Number: 1
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