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

Model Number	MRCS34
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, a memo 3d rechord semirigid annuloplasty ring mrcs34 was implanted on (b)(6) 2020.The device was explanted on (b)(6) 2021 and replaced with a new mrcs34.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.
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 to the manufacturer at the time of explant, no further investigation can be performed at this time.The manufacturer has requested additional information on the event and device in question, but no additional information has been provided to date.Based on the available information, it is not possible to draw a definitive conclusion to the reported event.However, from the document review performed, no manufacturing deficiencies have been identified.Should further information be provided in the future, the manufacturer will submit a follow up report to this reporting activity.At this time, the root cause cannot be established.

• 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
• MDR Report Key: 12025772
• Report Number: 1718850-2021-01119
• Device Sequence Number: 19918311
• Product Code: KRH
• UDI-Device Identifier: 08022057015105
• UDI-Public: (01)08022057015105(240)ICV1335(17)250108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021
• Report Date (Section F): 06/18/2021

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: 01/08/2025
• Device Model Number: MRCS34
• Device Catalogue Number: ICV1335
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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