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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVE DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND RING, ANNULOPLASTY Back to Search Results
Model Number 700FC
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
Event Type  Injury  
Manufacturer Narrative

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 implant of this 31mm annuloplasty band, the band was implanted, explanted and replaced with a 29mm annuloplasty band. The band was replaced with a smaller size due to surgeon preference. No additional adverse patient effects were reported.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

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Brand NameSIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana,ca
Manufacturer (Section G)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana,ca
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key7382190
MDR Text Key103854622
Report Number2025587-2018-00730
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number700FC
Device Catalogue Number700FC31
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 Received04/02/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/24/2017
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: 03/29/2018 Patient Sequence Number: 1
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