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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL MEMO 3D RECHORD 38MM; RING, ANNULOPLASTY
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SORIN GROUP ITALIA SRL MEMO 3D RECHORD 38MM; RING, ANNULOPLASTY Back to Search Results
Model Number MRCS
Device Problem Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 06/11/2017
Event Type  malfunction  
Event Description
The patient had minimally-invasive mitral valve repair approximately using a small right thoracotomy.This repair consisted of gore-tex neochordae placed to the a2 and p2 scallops of the anterior and posterior mitral valve leaflets supplemented with a 38 mm sorin memo 3d rechord annuloplasty band.Completion transesophageal echocardiography at that time revealed a well-seated band.A follow up tte at the 3 week mark which showed a stable mitral repair.Another tte two weeks later revealed a rocking annuloplasty band.Patient returned to operating room (or) and it was determined that approximately 2/3rds of the circumference of the prior annuloplasty band had dehisced completely from the mitral valve annulus.
 
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Brand Name
MEMO 3D RECHORD 38MM
Type of Device
RING, ANNULOPLASTY
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
14401 west 65th way
arvada CO 80004
MDR Report Key6672988
MDR Text Key78580319
Report Number6672988
Device Sequence Number1
Product Code KRH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMRCS
Device Catalogue NumberMRCS38
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2017
Date Report to Manufacturer06/16/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS
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