MAUDE Adverse Event Report: SORIN GROUP ITALIA MEMO 3D RECHORD

Model Number	MRCS32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/05/2016
Additional Manufacturer Narrative
The testing method will be determined upon receipt of additional information.Information regarding the reason for explant and the availability of the device is not available at this time.The manufacturer is reporting this event in a conservative manner.
Event or Problem Description
The manufacturer received a patient tracking form on 24-oct-2016 of the following: a memo 3d rechord was implanted and then explanted on (b)(6) 2016 at the (b)(6) medical center.
Event or Problem Description
The surgeon felt that the memo 3d rechord repair was insufficient after doing the implant and a resection.He decided a repair was not sufficient and he needed to replace the valve completely.He used a medtronic mitral valve instead.The patient did fine after the replacement.

• Brand Name: MEMO 3D RECHORD
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA; via crescentino sn; saluggia,
• MDR Report Key: 6142456
• Report Number: 3005687633-2016-00023
• Device Sequence Number: 16455786
• Product Code: KRH
• UDI-Device Identifier: 08022057015099
• UDI-Public: (01)08022057015099(240)ICV1334(17)210525
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

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: 05/25/2021
• Device Model Number: MRCS32
• Device Catalogue Number: ICV1334
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 04/27/2017
• 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: 75 YR