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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEART VALVES SANTA ANA SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY

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HEART VALVES SANTA ANA SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 800SR34
Device Problems Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility
Event Date 07/18/2017
Event Type  Injury  
Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation. 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 during the implant of this mitral annuloplasty ring the physician thought the ring fit too tight. The ring was removed and replaced with a larger ring of the same model. No additional adverse patient effects were reported.

 
Manufacturer Narrative

Pma number corrected. 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)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view , MN 55112
7635055378
MDR Report Key6803298
Report Number2025587-2017-01416
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number800SR34
Device Catalogue Number800SR34
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 Received08/18/2017
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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