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

Model Number SMD28

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

Patient Problem No Information (3190)

Event Date 07/25/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 a patient received a memo 3d semirigid annuloplasty ring, smd28, icv0968, as part of a mitral valve repair.The manufacturer was notified that the same day the device was explanted and replaced with a second memo 3d, however the size was increased to a smd32, icv0970.No further information was received.

Event Description

On (b)(6) 2019 a patient received a memo 3d semirigid annuloplasty ring, smd28, icv0968, as part of a mitral valve repair.The manufacturer was notified that the same day the device was explanted and replaced with a second memo 3d, however the size was increased to a smd32, icv0970.No further information was received.The manufacturer received additional information received on sep 27 2019 identifying the original repair didn't work as intended so the surgeon chose a larger size memo to create the correct repair.No allegations were made against the original device.It was regarded as simply a corrected mv repair.

Manufacturer Narrative

The manufacturer received additional information received on sep 27 2019 identifying the original repair didn't work as intended so the surgeon chose a larger size memo to create the correct repair.No allegations were made against the original device.It was regarded as simply a corrected mv repair.Based on the above information there is no indication that the event was related to any device related malfunction.The manufacturer will perform no further investigations and the root cause is deemed to be related to procedural changes.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9112927
• MDR Text Key: 161961241
• Report Number: 1718850-2019-01092
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057013118
• UDI-Public: (01)08022057013118(240)ICV0968(17)210816
• 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: 08/26/2019,10/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: SMD28
• Device Catalogue Number: ICV0968
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 10/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR