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

Model Number	AF-830
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown device disposition.
Event or Problem Description
The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, an annuloflex ring af-830 was implanted and explanted on the same day on (b)(6) 2021.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.
Additional 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.The manufacturer attempted to follow up to retrieve additional information on the event.However, no further information has been received to date.Since the device was not returned to the manufacturer, no further investigation can be performed at this time.Based on the available information, it is not possible to establish a definitive conclusion to the reported event.However, per the document review performed, no manufacturing deficiencies have been identified.Should further information be received in the future, the manufacturer will provide an update to this reporting activity.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• MDR Report Key: 12005842
• Report Number: 3005687633-2021-00140
• Device Sequence Number: 16970075
• Product Code: KRH
• UDI-Device Identifier: 08022057013620
• UDI-Public: (01)08022057013620(240)AF-830(17)250209
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 02/09/2025
• Device Model Number: AF-830
• Device Catalogue Number: AF-830
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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: Required Intervention
• Patient Age: 58 YR