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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 700
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2016
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen has not been returned for device evaluation. 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 the device be returned or additional information become available, a supplemental report will be submitted.

 
Event Description

Medtronic received information that immediately following implant of this annuloplasty ring, it was explanted and replaced as the surgeon did not like the size. No adverse patient effects were reported.

 
Manufacturer Narrative

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

 
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Brand NameSIMULUS FULLY FLEXIBLE ANNULOPLASTY 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 Key5807017
MDR Text Key49943795
Report Number2025587-2016-01095
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052565
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 07/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2020
Device MODEL Number700
Device Catalogue Number700FF29
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 Received07/05/2016
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

Patient TREATMENT DATA
Date Received: 07/19/2016 Patient Sequence Number: 1
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