MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 3D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number	SMD32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446)
Date of Event	09/04/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device memo3d #32 sn e81585b 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 is following up with the site to retrieve further information regarding this event and the device involved.A follow up report will be provided upon receipt of any further information.Unknown device disposition.
Event or Problem Description
The manufacturer was informed through mantra study that a patient implanted with a memo 3d size 32 mitral annuloplasty ring passed away on (b)(6) 2022.The event was a sudden death occurring during the night while the patient was sleeping.The ring had been implanted on (b)(6) 2021 through median sternotomy and concomitant cabg had been performed in the same surgery prior to ring implantation.The patient was in particularly complex health conditions and suffered from bronchopathy with sleep apnea.He had a previous history of coronary artery disease, myocardial infarction (<= 90 days at the time of surgery), ischemic heart failure, diabetes mellitus type ii, dyslipidemia.He also had a tobacco history and was nyha class iii.
Event or Problem Description
The manufacturer was informed through mantra study that a patient implanted with a memo 3d size 32 mitral annuloplasty ring passed away on (b)(6) 2022.The event was a sudden death occurring during the night while the patient was sleeping.The manufacturer was informed that autopsy was not performed.No other information is available regarding the event.The ring had been implanted on (b)(6) 2021 through median sternotomy and concomitant cabg (>4 vessels) had been performed in the same surgery prior to ring implantation.At the 30 days follow-up the echo exam showed an overall good functionality of the annuloplasty ring with trace of mitral regurgitation and no sam reported.Ef was 45% and lvedd 50 mm.Reportedly, the patient was in particularly complex health conditions and suffered from bronchopathy with sleep apnea.He had a previous history of coronary artery disease, myocardial infarction (<= 90 days at the time of surgery) , ischemic heart failure, diabetes mellitus type ii, dyslipidemia.He also had a tobacco history and was nyha class iii at the time of surgery.The site assessed the event as ¿possibly device related¿ since the relationship with the device cannot be excluded and probably related to other medical conditions due to the overall patient status (complex medical history, bronchopathy with sleep apnea).
Additional Manufacturer Narrative
No additional information relevant to the establishment of a possible root cause have been received by the manufacturer.As such, the manufacturer will close the case at this stage.Should further information be received in the future, the manufacturer will submit a new follow up report.

• Brand Name: MEMO 3D SEMIRIGID 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): CROCYM S.R.L; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 16782945
• Report Number: 3005687633-2023-00110
• Device Sequence Number: 5780967
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)260817
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 08/17/2026
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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: Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 58 KG