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

Model Number	MRCS28
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Mitral Insufficiency (1963)
Date of Event	08/22/2019
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.During the same surgery, three other concomitant procedures occurred: a tricuspid valve replacement with a 33mm edwards bioprosthesis, and a bi-atrial maze procedure, with ablation of both the anterior and posterior mitral trigones; a ligation of the left atrial appendage.An initial normal postoperative course was reported.The patient was seen in by a cardiologist for follow up visit on (b)(6) 2019.Low k level was noticed.The patient was consequently sent to ed on (b)(6) 2019 for further workup, and posterior ring dehiscence was noticed on the echo.The diagnosis was: hypokalemia, acute on chronic congestive heart failure, unspecified heart failure type.Currently, the patient presents severe mitral regurgitation and is very symptomatic with dyspnea, fatigue, orthopnea, and nocturnal desaturation. the patient was evaluated for a mitraclip but was found not to be a candidate due to insufficient access to leaflets.A re-do sternotomy and bioprosthetic mvr is planned, but no re-intervention has been performed yet.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.
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 explanted, 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: 9137666
• Report Number: 1718850-2019-01095
• Device Sequence Number: 16600439
• Product Code: KRH
• UDI-Device Identifier: 08022057015075
• UDI-Public: (01)08022057015075(240)ICV1332(17)231016
• 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
• 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: 10/16/2023
• Device Model Number: MRCS28
• Device Catalogue Number: ICV1332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2019
• Device Age: 10 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
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 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: Hospitalization
• Patient Age: 68 YR