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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY BAND RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY BAND RING, ANNULOPLASTY Back to Search Results
Model Number 800SC26
Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
Patient Problem Mitral Regurgitation (1964)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative

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 implant of this 26mm annuloplasty band in the mitral position, the band was explanted and replaced with a 34mm annuloplasty band due to residual regurgitation. No additional adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: event appears to be sizing related as the physician opted to use a larger band. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameSIMULUS SEMI-RIGID ANNULOPASTY 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 Key7517135
MDR Text Key108347402
Report Number2025587-2018-01141
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number800SC26
Device Catalogue Number800SC26
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 Received05/21/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/13/2016
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: 05/15/2018 Patient Sequence Number: 1
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