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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. MEMO 3D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

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SORIN GROUP ITALIA S.R.L. MEMO 3D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING Back to Search Results
Model Number MRCS32
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 08/13/2019
Event Type  Injury  
Event Description
A patient was intended to receive a memo3d-rechord #32 on (b)(6) 2019.The manufacturer was notified the device was implanted and explanted on the same day.No further information was received.
 
Manufacturer Narrative
The manufacturer received information from the site on nov.05, 2019.The site reported the failure to implant was not a result of any device related malfunctions or faults.Based on this assessment the root cause of the reported event is thus attributed to procedural issues and is not device related.
 
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Brand Name
MEMO 3D SEMIRIGID ANNULOPLASTY RING
Type of Device
MITRAL ANNULOPLASTY RING
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia, vc
MDR Report Key9199881
MDR Text Key162642756
Report Number1718850-2019-01114
Device Sequence Number1
Product Code KRH
UDI-Device Identifier08022057015099
UDI-Public(01)08022057015099(240)ICV1334(17)230927
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 09/16/2019,12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/27/2023
Device Model NumberMRCS32
Device Catalogue NumberICV1334
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/16/2019
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer09/16/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2019
Supplement Dates Manufacturer Received09/16/2019
Supplement Dates FDA Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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