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	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on this event through the device tracking department.On (b)(6) 2020, a memo 3d #32 was implanted and explanted intraoperatively.No additional information is available at this time.No complaint received from the site regarding this event.
Additional Manufacturer Narrative
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.
Event or Problem Description
The manufacturer was informed on this event through the device tracking department.On 07 feb 2020, a memo 3d #32 was implanted and explanted intraoperatively.No complaint received from the site regarding this event.Per additional information received, the ring was explanted intraoperatively due to a failed repair, ultimately converted to a full valve replacement.The ring was discarded.The pre-operative diagnosis was of severe, symptomatic mitral insufficiency.The op note reports that there was a ruptured p2 chord, and a repair of the valve was initially attempted to ameliorate the insufficiency.After the implant of the 32 memo 3d ring, "saline testing at this point showed that there was an asymmetric billowing of a1 and a2 that had not been appreciated and there was a significant leak.The ring was removed and the anterior leaflet excised.A 31 mm medtronic mosaic porcine tissue valve was implanted".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: 9944196
• Report Number: 1718850-2020-01064
• Device Sequence Number: 19528772
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)240729
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020
• Report Date (Section F): 03/13/2020

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: 07/29/2024
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/09/2020
• 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: 65 YR