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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 800
Device Problems Incomplete Coaptation (2507); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative

The device has not been received for analysis. Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation. Additional information has been requested, but no new information has been received to date.

 
Event Description

Medtronic received information indicating that immediately post implant of this annuloplasty ring in the mitral position, this ring was explanted. No failure mechanism and no other adverse patient effects were reported.

 
Manufacturer Narrative

Medtronic received additional information that this annuloplasty ring was replaced because there was a perforation of the p3 leaflet, and the p1 leaflet was inadequate to allow coaptation following the repair; this ring was replaced with a 27 mm valve. There was not likely a fault with the ring. The replacement was more do the fact the patient¿s valve could not be repaired. As a result of the replacement procedure, the patient experienced prolonged pump time and prolonged anesthesia. No other adverse patient effects were reported. 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.

 
Manufacturer Narrative

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)
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 Key6188125
MDR Text Key62787294
Report Number2025587-2016-02047
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072655
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device MODEL Number800
Device Catalogue Number800SR26
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 Received01/12/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/31/2014
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: 12/20/2016 Patient Sequence Number: 1
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