MAUDE Adverse Event Report: CORCYM S.R.L. ANNULOFLEX MITRAL ANNULOPLASTY RING

Model Number AF-830

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

Unknown device disposition.

Event Description

The manufacturer was informed of the following event through patient tracking department.Based on the patient registration form (prf) received, an annuloflex mitral annuloplasty ring, af-830, was implanted and explanted on the same day on (b)(6) 2023 in a patient.No allegation of device malfunction nor the serious injury on the patient has been received from the site regarding this event.

Event Description

The manufacturer was informed of the following event through patient tracking department.Based on the patient registration form (prf) received, an annuloflex mitral annuloplasty ring, af-830, was implanted and explanted on the same day on (b)(6) 2023 in a patient.No allegation of device malfunction nor the serious injury on the patient has been received from the site regarding this event.Based on the further information received, ring was explanted due to the sam.Reportedly, no malfunction with the device was noted and the outcome of the patient is good.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.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.Based on the medical judgement available, there was no malfunction with the device.Furthermore, from the document review performed, no manufacturing deficiencies were noted.As such, cause of the event cannot be traced to the device.Should further information be received in the future, a follow up report will be provided.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16736414
• MDR Text Key: 313255420
• Report Number: 3005687633-2023-00108
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057013620
• UDI-Public: (01)08022057013620(240)AF-830(17)270621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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 Model Number: AF-830
• Device Catalogue Number: AF-830
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female