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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVE DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 800
Device Problems Incomplete Coaptation; Adverse Event Without Identified Device or Use Problem
Event Date 04/11/2018
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 following the implant of this annuloplasty ring, after repairing the mitral valve and implanting the ring, echocardiogram revealed incomplete coaptation with mild regurgitation. Cardiopulmonary bypass (cpb) was re-initiated and the ring was explanted and replaced with a non-medtronic ring. No additional adverse patient effects were reported.

 
Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, there was no evidence of distortion. Radiography showed no fractures in the ring nor any presence of calcification. Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution. No issues were identified that would have impacted this event. There were no anomalies noted during analysis that may have contributed to the reported clinical observation. 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 VALVE DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVE 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 Key7502787
Report Number2025587-2018-01103
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number800
Device Catalogue Number800SR30
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/29/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/16/2017
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: 05/10/2018 Patient Sequence Number: 1
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