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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION SIMULUS ADJUSTABLE ANNULOPLASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 735
Device Problem Human-Device Interface Problem
Event Date 12/04/2015
Event Type  Injury  
Manufacturer Narrative

The device serial number was not reported. Without the serial number, the device manufacturing date and expiration date cannot be obtained. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. (b)(4).

 
Event Description

Medtronic received information that four years, five months post implant of this annuloplasty ring in the mitral position, the device became detached along most of the anterior portion and part of one side posterior due to dehiscence. The patient's native valve also had severe central regurgitation. The device was explanted and replaced with a bioprosthetic valve. No further adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: reoperations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions. In this case, there is no allegation of ring malfunction. Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair. The device was explanted 4 years post implant due to dehiscence and the native valve¿s severe central regurgitation, which may be related to the progression of the native valve disease. (b)(4).

 
Manufacturer Narrative

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

 
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Brand NameSIMULUS ADJUSTABLE 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 STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view , MN 55112
7635055378
MDR Report Key5355866
Report Number2025587-2016-00033
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number735
Device Catalogue Number735AF
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 Received02/05/2016
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

Patient TREATMENT DATA
Date Received: 01/08/2016 Patient Sequence Number: 1
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