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

Model Number	MRCS34
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
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.Since the device was not returned, no further investigation is possible at this time.Based on the information available, it is not possible to establish a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.The manufacturer has requested additional information on the event and the device involved.Should any further information be received, a follow up report will be provided as applicable.
Event or Problem Description
The manufacturer was informed of this event through the device tracking department.Based on the information reported on the patient implant form, a memo 3d rechord semirigid annuloplasty ring mrcs34 was implanted and explanted on (b)(6) 2022.The manufacturer has not received from the site any allegation of a device malfunction nor of serious injury regarding this event.
Additional Manufacturer Narrative
Based on the information available and medical judgment received, the device can be reasonably excluded as cause or contributing factor to the reported event.The intraoperative explant was reported as a clinical decision.Thus, no further investigation is warranted at this time, and the case is considered closed.
Event or Problem Description
The manufacturer was informed of this event through the device tracking department.Based on the information reported on the patient implant form, a memo 3d rechord mrcs34 was implanted and explanted on (b)(6) 2022.The manufacturer has not received from the site any allegation of a device malfunction nor of serious injury regarding this event.Upon follow up, the surgeon reported that it was a clinical decision and there was no complaint or issue with the ring used.No further information was provided.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 14376232
• Report Number: 3005687633-2022-00123
• Device Sequence Number: 11264689
• Product Code: KRH
• UDI-Device Identifier: 08022057015105
• UDI-Public: (01)08022057015105(240)ICV1335(17)250908
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 09/08/2025
• Device Model Number: MRCS34
• Device Catalogue Number: ICV1335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female