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

Model Number	SMD26
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	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) , 2018 a memo 3d smd26 semirigid annuloplasty mitral repair ring was implanted.The manufacturer received a notification that the valve was explanted the same day and replaced with a memo 3d smd28 repair ring.
Additional Manufacturer Narrative
Additional information provided on (b)(6) 2018 clarified that the size 26 memo 3d ring was never implanted.It was opened, the valve was resized and a different valve was used.No adverse effects to the patient as a result.Event is not device related.No further follow-up.
Event or Problem Description
On (b)(6) 2018 a memo 3d smd26 semirigid annuloplasty mitral repair ring was implanted.The manufacturer received a notification that the valve was explanted the same day and replaced with a memo 3d smd28 repair ring.Additional information provided clarified that the size 26 memo 3d ring was never implanted.It was opened, the valve was resized and a memo 3d smd28 was used.No adverse effects to the patient as a result.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7465669
• Report Number: 3005687633-2018-00144
• Device Sequence Number: 1717254
• Product Code: KRH
• UDI-Device Identifier: 08022057013101
• UDI-Public: (01)08022057013101(240)ICV0967(17)211220
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: Physician
• Device Expiration Date: 12/20/2021
• Device Model Number: SMD26
• Device Catalogue Number: ICV0967
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/02/2018
• 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: 76 YR