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

Model Number	SMD28
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location not presently known.
Event or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
Fields updated: b4, b5, d10, g4, g7, h1, h2, h3, h6.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.Device discarded by the hospital.

• Brand Name: MEMO 3D SEMI-RIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9936488
• Report Number: 3005687633-2020-00115
• Device Sequence Number: 701058
• Product Code: KRH
• UDI-Device Identifier: 08022057013118
• UDI-Public: (01)08022057013118(240)ICV0968(17)231106
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR