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

Model Number	AF-832
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
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, a annuloflex-size 32 valve was implanted and explanted on (b)(6) 2021.The manufacturer did not received any allegation of a device malfunction or a serious injury for the patient from the hospital regarding this event.
Additional Manufacturer Narrative
Unknown device disposition.
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 there is no information about the disposition of the valve and the device was not returned to the manufacture, the investigation on the device is not possible.The manufacturer attempted to retrieve additional information on the event reported and the device disposition, but no further information was received.Based on the limited information available, it is not possible to establish a definitive root cause for reported intraoperative device explant.However, from the document review performed, no manufacturing deficiencies were identified.The manufacturer attempted to follow up with the field, but no further information was received up to date.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: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13085387
• Report Number: 3005687633-2021-00169
• Device Sequence Number: 14793686
• Product Code: KRH
• UDI-Device Identifier: 08022057013637
• UDI-Public: (01)08022057013637(240)AF-832(17)240601
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 06/01/2024
• Device Model Number: AF-832
• Device Catalogue Number: AF-832
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/24/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Unknown