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

Model Number	MRCS32
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer narrative, the physician initially attempted to repair the mitral valve with the memo 3d.The repair was insufficient, and a mvr was performed.Based on this narrative, the event is attributable to the operational context, as the repair was not sufficient.This event has been deemed not device related, and no further investigation is required.
Event or Problem Description
An attempt was made to repair the mitral valve with a memo 3d annuloplasty ring, but the surgeon was not satisfied with the repair.He decided to replace the mitral valve, and implanted a magna mitral valve size 31 mm.The patient did well, and the memo 3d was discarded.This event occurred on (b)(6) 2017.Livanova canada corp was notified on september 6, 2017 of this event through patient tracking.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• MDR Report Key: 6921685
• Report Number: 3005687633-2017-00097
• Device Sequence Number: 827736
• Product Code: KRH
• UDI-Device Identifier: 08022057015099
• UDI-Public: (01)08022057015099(240)ICV1334(17)210907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 10/06/2017

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: 09/07/2021
• Device Model Number: MRCS32
• Device Catalogue Number: ICV1334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/06/2017
• 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: 64 YR