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

Model Number	AR-730
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed of this event through patient tracking database.Based on the information received from the patient implant form, on (b)(6) 2020, the annuloflo mitral annuloplasty ring size 30 was implanted and explanted intra-operatively.No allegation of a device malfunction nor of a serious injury for the patient was received from the hospital regarding this event.
Additional Manufacturer Narrative
Unknown device disposition.
Additional Manufacturer Narrative
The manufacturer attempted to retrieve additional information on this event, and the device involved.However, no further information has been provided to date, despite the manufacturer's attempts.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 at the time of explant (unknown disposition), no further investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity as deemed applicable.

• Brand Name: ANNULOFLO 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: 13745368
• Report Number: 3005687633-2022-00106
• Device Sequence Number: 4761956
• Product Code: KRH
• UDI-Device Identifier: 08022057013682
• UDI-Public: (01)08022057013682(240)AR-730(17)241012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 04/12/2022

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: 10/12/2024
• Device Model Number: AR-730
• Device Catalogue Number: AR-730
• Was Device Available for Evaluation?: No
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male