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

Model Number MRCS30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Unable to follow up on ring disposition.

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.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.

Manufacturer Narrative

Fields changed: date of report, date received by mfr, type of report, type of reportable event, follow up type, evaluation codes.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.

Manufacturer Narrative

Additional information received and clarified initial detection of the ring dehiscence (aug 2019 instead of jun 2019).

Event Description

It was clarified that the ring dehiscence was firstly noticed on (b)(6) 2019.The remainder of the information is unchanged.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9141101
• MDR Text Key: 166497685
• Report Number: 3005687633-2019-00227
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015082
• UDI-Public: (01)08022057015082(240)ICV1333(17)231023
• Combination Product (y/n): N
• PMA/PMN Number: K071327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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: 10/23/2023
• Device Model Number: MRCS30
• Device Catalogue Number: ICV1333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/04/2019; 10/14/2019
• Supplement Dates FDA Received: 10/31/2019; 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention