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

Model Number MRCS28

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Dyspnea (1816); Fatigue (1849); Mitral Insufficiency (1963)

Event Date 08/22/2019

Event Type  Injury  

Event 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.

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
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9137666
• MDR Text Key: 161961525
• Report Number: 1718850-2019-01095
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015075
• UDI-Public: (01)08022057015075(240)ICV1332(17)231016
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/04/2019,11/08/2019

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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR