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

Model Number	MRCS26
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information the manufacturer is reporting this event in a conservative manner.A company representative is in the process of following up with the physician to determine further information.This was the physician's first use of memo 3d rechord.Not yet determined if device available.
Event or Problem Description
On (b)(4) 2017 the manufacturer was notified through patient tracking of an event that occurred on (b)(6), the information received to date is of a memo3d-rechord mrcs26 (sn# (b)(4)) that was implanted and explanted.On the same day.
Additional Manufacturer Narrative
In the initial report the following information was inadvertently omitted: it was reported that this was the surgeon's first time using the memo 3d rechord, and that he had no support during the procedure.The explant was attributed to physician error due to inexperience.Based on the information available, there is no indication of an inadequacy of the device, and the event can be attributed to operational context.No device investigation is therefore warranted at this time.Device not returned.

• Brand Name: MEMO 3D RECHORD 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: 6750864
• Report Number: 3005687633-2017-00079
• Device Sequence Number: 856330
• Product Code: KRH
• UDI-Device Identifier: 08022057015068
• UDI-Public: (01)08022057015068(240)ICV1331(17)210118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/22/2017

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: 01/18/2021
• Device Model Number: MRCS26
• Device Catalogue Number: ICV1331
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 12/22/2017
• 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: 62 YR