MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 4D ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number	4DM-26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
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 at the time of explant (unknown disposition), no further investigation is possible at this time.The manufacturer attempted to retrieve additional information on this event, and the device involved.However, no further information has been provided up to this date.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.The manufacturer is following up with the field.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity as deemed applicable.
Event or Problem Description
The manufacturer was informed of this event through the patient tracking department.Based on the information reported in the patient implant form, a memo 4d annuloplasty ring 4dm-26 was implanted and explanted on (b)(6) 2022.No further information is presently available.No allegation of any device malfunction nor of a serious injury was received from the site regarding this event.

• Brand Name: MEMO 4D ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vereclli 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 13934755
• Report Number: 3005687633-2022-00112
• Device Sequence Number: 11944905
• Product Code: KRH
• UDI-Device Identifier: 08022057015419
• UDI-Public: (01)08022057015419(240)4DM-26(17)250416
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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: 04/16/2025
• Device Model Number: 4DM-26
• Device Catalogue Number: 4DM-26
• 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: 03/02/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2020
• 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: 69 YR
• Patient Sex: Female