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

Model Number	SMD32
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	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition unknown.
Event or Problem Description
The manufacturer was informed on this event through the device tracking team.Per the information reported in the patient implant form, on (b)(6) 2020 a patient received a memo 3d #32 in mitral position.The device was explanted intraoperatively.No other information is presently available.No complaint has been received from the site regarding this event.
Additional Manufacturer Narrative
Fields updated: b4, b5, g4, g7, h1, h2, h3, h6.Based on the additional information received, no allegation of a device malfunction was reported and the root cause of the intra-operative explant can be reasonably attributed to patient factors that precluded adequate repair with an annuloplasty ring, in line with livanova's clinical experience.As such, the event is not related to a deficiency of the device and, therefore, no further investigation is warranted at this time.H3 other text : device discarded.
Event or Problem Description
The manufacturer was informed on this event through the device tracking team.Per the information reported in the patient implant form, on (b)(6) 2020 a patient received a memo 3d #32 in mitral position.The device was explanted intraoperatively.No complaint has been received from the site regarding this event.Per additional information received, it was confirmed that the ring was explanted intraoperatively due to a failed repair, thus the procedure was converted from a valve repair to a valve replacement.The ring was discarded.As confirmed by the operative note received, after the attempted repair 'the anterior leaflet prolapse was now quite evident and the valve required replacement'.The patient was not adversely impacted by the event based on the report received.

• 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: 9912435
• Report Number: 3005687633-2020-00112
• Device Sequence Number: 16982893
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)240624
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• 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: 06/24/2024
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/01/2020
• 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: 59 YR