MAUDE Adverse Event Report: CORCYM S.R.L MEMO3D-RECHORD #32; MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING

Model Number	MRCS32
Medical Device Problem Codes	Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown disposition.
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 size 32 was implanted on (b)(6) 2019.It was explanted on (b)(6)2021 and replaced with a carbomedics optiform mitral heart valve f7-029.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.
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 size 32 was implanted on (b)(6) 2019.It was explanted on (b)(6) 2021 and replaced with a carbomedics optiform mitral heart valve f7-029.Based on the additional information received from the operational report, the patient presented previous mitral valve stenosis and insufficiency after prior mitral valve and had undergone a transcatheter mitral valve ( edwards transcatheter valve leading to a paravalvular leak).The annulus of the previous annuloplasty ring had pulled away from the posterior leaflet resulting in a paravalvular leak.The edwards transcatheter valve and the memo 3d ring were explanted on (b)(6) 2021 and replaced with a carbomedics optiform mitral heart valve f7-029.The patients medical history includes hodgkin disease, acute-on-chronic congestive heart failure, hyperlipidemia, transcatheter mitral valve in mitral valve ring annulus and chronic obstructive pulmonary disease.Patient was returned to icu in a stable condition and their discharge condition was good.
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 the root cause can not be determined.Following the results from the dhr there were no issues found with the device.The device was explanted but not returned, therefore no further investigation can be performed.Should the manufacturer received additional information in the future regarding this event, the manufacturer will give a follow up report.
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 size 32 was implanted on (b)(6) 2019.It was explanted on (b)(6) 2021 and replaced with a carbomedics optiform mitral heart valve f7-029.Based on the additional information received from the operational report, the patient presented previous mitral valve stenosis and insufficiency after prior mitral valve and had undergone a transcatheter mitral valve ( edwards transcatheter valve leading to a paravalvular leak).The annulus of the previous annuloplasty ring had pulled away from the posterior leaflet resulting in a paravalvular leak.The edwards transcatheter valve and the memo 3d ring were explanted on (b)(6) 2021 and replaced with a carbomedics optiform mitral heart valve f7-029.The patients medical history includes hodgkin disease, acute-on-chronic congestive heart failure, hyperlipidemia, transcatheter mitral valve in mitral valve ring annulus and chronic obstructive pulmonary disease.Patient was returned to icu in a stable condition and their discharge condition was good.Based on information received there was no degeneration noted on the memo 3d rechord valve during the reintervention the valve was intact.The memo 3d rechord required intervention due to mitral regurgitation.

• Brand Name: MEMO3D-RECHORD #32
• Common Device Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L; strada crescentino; saluggia, vercelli
• MDR Report Key: 11962515
• Report Number: 3005687633-2021-00138
• Device Sequence Number: 19744848
• Product Code: KRH
• UDI-Device Identifier: 08022057015099
• UDI-Public: (01)08022057015099(240)ICV1334(17)221102
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2021

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: 11/02/2022
• Device Model Number: MRCS32
• Device Catalogue Number: ICV1334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 08/19/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/27/2021; 09/14/2021
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 59 YR