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 Code	Dyspnea (1816)
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.
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.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.
Additional Manufacturer Narrative
Fields changed: 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: 9142693
• Report Number: 3005687633-2019-00228
• Device Sequence Number: 2941708
• Product Code: KRH
• UDI-Device Identifier: 08022057015075
• UDI-Public: (01)08022057015075(240)ICV1332(17)231219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 12/19/2023
• Device Model Number: MRCS28
• Device Catalogue Number: ICV1332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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