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

Model Number	MRCS30
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Congestive Heart Failure (1783); No Information (3190)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a mitral valve repair with a memo 3d-rechord was performed.The implant of the ring was performed using the horizontally mattressed 2-0 ticron circumferentially.On (b)(6) 2019, ring dehiscence was detected through the echo.The patient was admitted to the icu (diagnosis: congestive heart failure, nyha class ii) and then transferred to the cleveland clinic, where a mitral valve replacement was performed (exact date of surgery unknown).Following the second surgery, the patient had a brain bleed with left-sided weakness.Based on the physician's assessment, a potential contributory factor to the reported dehiscence could be identified in the stitching area, which was reportedly very thin.
Event or Problem Description
It was clarified that the ring dehiscence was firstly noticed on (b)(6) 2019.The remainder of the information is unchanged.
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 manufacturer was unable to follow up on the device disposition after the explant, no device inspection can be performed at this time.Based on the information available, it is not possible to establish the root cause of the event.However, based on the document review, no manufacturing nor quality deficits were identified.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9141031
• Report Number: 1718850-2019-01096
• Device Sequence Number: 3046967
• Product Code: KRH
• UDI-Device Identifier: 08022057015082
• UDI-Public: (01)08022057015082(240)ICV1333(17)231023
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2019
• Report Date (Section F): 09/04/2019

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: 10/23/2023
• Device Model Number: MRCS30
• Device Catalogue Number: ICV1333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2019
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2019; 09/04/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/08/2019
• 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