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

Model Number	SMD30
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is in the process of following up with the physician to determine further information on this event.This event is being reported in a conservative manner due to limited information.Not yet determined if device available.
Event or Problem Description
On (b)(6) 2017 the manufacturer was notified through patient tracking of memo 3d size 30 (sn# (b)(4)) that was implanted and explanted on the same day (b)(6) 2017.
Additional Manufacturer Narrative
The manufacturer received additional information confirming that the patient's anatomy was not suitable repair with a mitral ring, and the event was therefore not device-related.As the root cause of the event can be attributed to the patient's anatomy, no further investigation is warranted at this time.Device not available for return.
Event or Problem Description
On (b)(6) 2017 the manufacturer was notified through patient tracking of memo 3d size 30 (sn# (b)(4) that was implanted and explanted on the same day (b)(6) 2017.It was reported that the patient's anatomy was not suitable for a repair, regardless of the type of mitral ring.

• 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: 6933813
• Report Number: 3005687633-2017-00098
• Device Sequence Number: 1408579
• Product Code: KRH
• UDI-Device Identifier: 08022057013125
• UDI-Public: (01)08022057013125(240)ICV0969(17)220228
• 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): 12/20/2017

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: Physician
• Device Expiration Date: 02/28/2022
• Device Model Number: SMD30
• Device Catalogue Number: ICV0969
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 12/20/2017
• 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: 63 YR