MAUDE Adverse Event Report: SORIN GROUP ITALIA MEMO 3D SEMIRIGID ANNULOPLASTY RING; MEMO3D #28

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	03/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On march 22 2017 the manufacturer was notified through patient registration form that a memo 3d semirigid annuloplasty ring was attempted to be implanted.The device was removed and mitral valve replacement was performed.
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem Description
On (b)(6) 2017 during a mitral valve repair procedure, the failure to implant the memo 3d was due to physician medical judgment during the procedure that a mitral valve replacement was required and.As per medical judgment no issue with the memo 3d device.The ring was removed and the physician performed a mitral valve replacement.The device has been discarded by the hospital.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO3D #28
• Manufacturer (Section D): SORIN GROUP ITALIA; via crescentino sn; saluggia, it 13040 ; IT 13040
• MDR Report Key: 6517037
• Report Number: 3005687633-2017-00039
• Device Sequence Number: 19133103
• Product Code: KRH
• UDI-Device Identifier: 08022057013118
• UDI-Public: (01)08022057013118(240)ICV0968(17)210530
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 05/30/2021
• Device Model Number: SMD28
• Device Catalogue Number: ICV0968
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 11/12/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 11/15/2017
• 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: 71 YR