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

Model Number	AF-830
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown device disposition.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005687633-2023-00108
• Device Sequence Number: 15121684
• Product Code: KRH
• UDI-Device Identifier: 08022057013620
• UDI-Public: (01)08022057013620(240)AF-830(17)270621
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female