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

Model Number	AF-832
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Insufficient Information (4580)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, an annuloflex /annuloplasty ring af-832 was implanted on (b)(6) 2015.As of (b)(6) 2021, the patient is reported to have a mitral valve stenosis and undergoing an evaluation for a re-operation at banner heart hospital.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.
Event or Problem Description
The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, an annuloflex annuloplasty ring af-832 was implanted on (b)(6) 2015.As of (b)(6) 2021, the patient is reported to have a mitral valve stenosis and undergoing an evaluation for a re-operation.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.The manufacturer has followed up and received the following information from the hospital.The patient had a surgery in 2015 where one repair and one replacement was planned, but ultimately received 2 valves (aortic and mitral).The patient received a 29mm st jude epic valve in mitral position, which required a re-intervention for mitral stenosis on (b)(6) 2021.A transcatheter mitral valve replacement with a 26-mm sapiens s3 valve was performed., with a good outcome.
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.Since the device was not returned to the manufacturer, no further investigation is possible at this time.Based on the additional information received, it appears that the corcym device was attempted to be implanted from the operational report the coding has been revised.This event is not related to the annuloflex ring, the tavi procedure is related to a saint jude valve.The root cause can be attributed to patient conditions.Based on the dhr there appears to be no issue with the valve, since the valve is not being returned no further investigation can be performed at this time.

• Brand Name: CARBOMEDICS ANNULOFLEX ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia 13040 ; IT 13040
• MDR Report Key: 11898675
• Report Number: 1718850-2021-01104
• Device Sequence Number: 11612965
• Product Code: KRH
• UDI-Device Identifier: 08022057013637
• UDI-Public: (01)08022057013637(240)AF-832(17)170604
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021
• Report Date (Section F): 09/09/2021

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: 06/04/2017
• Device Model Number: AF-832
• Device Catalogue Number: AF-832
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2021
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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: Other
• Patient Age: 72 YR