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

Model Number SMD32

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 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Device disposition unknown.

Event 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.

Event 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 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.

Manufacturer Narrative

Fields updated: b4, b5, d10, 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 by the hospital.

• 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: 9944205
• MDR Text Key: 187109363
• Report Number: 3005687633-2020-00116
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)240729
• Combination Product (y/n): N
• PMA/PMN Number: K071327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR