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 Problem Dyspnea (1816)

Event Date 06/15/2019

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.Other concomitant procedures were also performed (coronary artery bypass grafting x 1, intraoperative coronary angiography of the lima-lad anastomosis; insertion of right common femoral arterial intra-aortic balloon pump).On (b)(6) 2019, the patient was admitted on (b)(6) 2019 to the emergency department for shortness of breath.The diagnosis was of acute on chronic congestive heart failure, atrial fibrillation with rvr, elevated serum creatinine, pneumonia due to organism.On (b)(6) 2019, ring dehiscence was detected through the echo.The patient is being monitored but the ring has not been explanted yet.The current diagnosis is of dilated cardiomyopathy, essential hypertension, and paroxysmal atrial fibrillation.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: 9142686
• MDR Text Key: 161965240
• Report Number: 1718850-2019-01097
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015075
• UDI-Public: (01)08022057015075(240)ICV1332(17)231219
• 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: 09/04/2019,11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2023
• 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: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 09/04/2019
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization