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

Model Number	MRCS32
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2020 a patient received a memo-3d rechord mechanical ring as part of an mitral valve repair.The manufacturer was notified that mitral regurgitation was observed, and the site recommended re-valvuloplasty however the patient wanted to replace the valve.On (b)(6) 2020, memo 3d was explanted and epic (29mm) was implanted.Patient was in good condition after operation.No further information was received.
Additional Manufacturer Narrative
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 available information, it is not possible to draw a definitive conclusion regarding the reported event.The review of the device history record showed that this valve satisfied all material, visual, and performance standards required at the time of manufacture and release.The manufacturer attempted to follow up further on this event, but no additional information been received to date (follow-up challenged by covid-19 outbreak).The case will be closed at this time under the memo cp_mir_mis_001530 as no further investigation is possible.However, should additional information be provided, the manufacturer will re-assess the event and take further investigative action as applicable.The root cause is thus deemed to be cause not established.Fields changed: b4, g4, g7, h2, h6.

• 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: 9951720
• Report Number: 3005687633-2020-00117
• Device Sequence Number: 2319984
• Product Code: KRH
• UDI-Device Identifier: 08022057015099
• UDI-Public: (01)08022057015099(240)ICV1334(17)240507
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 05/07/2024
• Device Model Number: MRCS32
• Device Catalogue Number: ICV1334
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 04/11/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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