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

Model Number SMD28

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/23/2019

Event Type  Injury  

Event Description

The manufacturer was informed on this event through the device tracking team.Based on the information available on the patient implant form, on (b)(6) 2019, a memo3d #28 was implanted/explanted intraoperatively.No further information on the event or on the device disposition is presently available.No complaint has been received from the site pertaining to this event.

Manufacturer Narrative

Based on additional information received, the device was explanted due to an unsuccessful repair of the mitral valve; a full replacement was consequently performed.Based on livanova's clinical experience, an intra-operative explant of a mitral ring followed by total mitral valve replacement is attributable to patient factors that precluded adequate repair with an annuloplasty ring.Furthermore, no allegation of a device malfunction was received and no serious injury for the patient is reported.As such, the event is not related to a deficiency of the device and, therefore, no further investigation is warranted at this time.

Event Description

The manufacturer was informed on this event through the device tracking team.Based on the information available on the patient implant form, on (b)(6) 2019, a memo3d #28 was implanted/explanted intraoperatively.No complaint has been received from the site pertaining to this event.Per additional information received, the ring was explanted intraoperatively due to a failed repair, and the procedure was converted to a full valve replacement with a bioprosthetic valve (31mm mosaic tissue valve).The ring was discarded.The procedure was completed with no complications based on the information received.

• Brand Name: MEMO 3D SEMI-RIGID ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9936446
• MDR Text Key: 191197117
• Report Number: 1718850-2020-01062
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057013118
• UDI-Public: (01)08022057013118(240)ICV0968(17)231106
• 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: 03/10/2020,05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2023
• Device Model Number: SMD28
• Device Catalogue Number: ICV0968
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR