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

Model Number	MRCS34
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disposition not presently known.
Event or Problem Description
It was reported that a memo3d rechord, size 34, was implanted and explanted intra-operatively on (b)(6) 2018.No other information was provided.
Additional Manufacturer Narrative
The manufacturer was unable to obtain additional information regarding the details of this event, despite several attempts to follow up.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the document review performed, no manufacturing deficiencies were identified.However, as the device was not received for analysis and limited information was provided, the root cause of the event cannot be determined.This event was reported in a conservative manner; however, it has not been confirmed whether the reported incident represents an adverse event.If additional information is received in the future, the case will be re-assessed and appropriate investigative action will be taken.Unable to follow up; not returned.

• 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, vc
• MDR Report Key: 8052366
• Report Number: 3005687633-2018-00208
• Device Sequence Number: 1485192
• Product Code: KRH
• UDI-Device Identifier: 08022057015105
• UDI-Public: (01)08022057015105(240)ICV1335(17)230425
• Combination Product (Y/N): N
• 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): 12/21/2018

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: Health Professional
• Device Expiration Date: 04/25/2023
• Device Model Number: MRCS34
• Device Catalogue Number: ICV1335
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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