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

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.

• 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 Key: 9199881
• MDR Text Key: 162642756
• Report Number: 1718850-2019-01114
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015099
• UDI-Public: (01)08022057015099(240)ICV1334(17)230927
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Date: 09/27/2023
• Device Model Number: MRCS32
• Device Catalogue Number: ICV1334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2019
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR