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

Model Number	AF-830
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on this event through the patient tracking department.Based on the information reported on the patient implant form, an annuloflex mitral annuloplasty ring af-830 was implanted and explanted intra-operatively on (b)(6) 2022.No allegation of device malfunction nor serious injury on the patient regarding this event has been received form the hospital.
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.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.Based on the limited information available, 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, a follow up report will be provided.
Additional Manufacturer Narrative
Based on the information available, the mitral ring was explanted intra-operatively and followed by total mitral valve replacement.Based on the manufacturer's clinical experiences, the root cause of these events are attributable either to the procedure or patient factors that precluded adequate repair with an annuloplasty ring.This is align with the information received ''there was evidence of excess anterior leaflet that was causing sam physiology which led to hemodynamic instability not easily relieved by decreasing inotropy and hr and volume loading.This was not going to be a reasonable result and given the patient's depressed function while weaning cb, the decision was made to replace the mitral valve.'' as such, there is no indication of relationship with the device and cause of the reported event was attributed to the procedure.Should further information be received in the future, the manufacturer will provide a follow up report.
Event or Problem Description
The manufacturer was informed on this event through the patient tracking department.Based on the information reported on the patient implant form, an annuloflex mitral annuloplasty ring af-830 was implanted and explanted intra-operatively on (b)(6) 2022.No allegation of device malfunction nor serious injury on the patient regarding this event has been received form the hospital.Based on additional information received, patient was reported with doe, fatigue.Tte and lhc revealed mr and multivessel cad.As such, the decision of re-surgery was made.Intra-operative transesophageal echocardiogram was and revealed lvef 60-65%, normal rv, severe mr with p1/3 prolapse and normal annulus.On inspection of mitral valve, the underlying cause of the pathology for the mitral regurgitation with a p1/p2 prolapse and p1/p2 and p2/p3 clefts was easily identified.This appeared amenable to repair.A p2 quadrangular resection to the p1 side was performed.The remaining p2 leaflet and p1 were brought together and the p2/p3 cleft was closed.The valve was tested and found to be without regurgitation.Then the repair was supported with a flexible annuloplasty ring.30 mm carbomedics annuloflex simulus flexible ring was chosen.After implanting the ring, the left atriotomy was closed using running horizontal mattress technique to ensure endocardial to endocardial apposition and a second layer running stitch.The right atriotomy was closed and other necessary steps was performed.The heart was de-aired, the aortic cross-clamp removed and ventilation restarted.On tee, a mild depressed biventricular function with no residual mitral regurgitation and a mitral gradient of 5 mmhg was noted.However, there was evidence of excess anterior leaflet that was causing sam physiology which led to hemodynamic instability not easily relieved by decreasing inotropy and hr and volume loading.This was not going to be a reasonable result and given the patient's depressed function while weaning cb, the decision was made to replace the mitral valve.As such, the mitral valve ring was removed and the mid portion of the anterior leaflet was resected and 31 mm epic valve was chosen to be implanted.The valve was seated with appropriate placement in the mitral position.Tee showed normal lv function but depressed rv function, no residual mitral regurgitation and a mitral gradient of 3 mmhg.Protamine was administered and the heart was then decannulated.There was diffuse coagulopathy requiring administration of multiple blood products to achieve hemostasis.There was also a small injury to the right middle lobe that had profuse venous bleeding that required a small wedge resection.All surgical sites were inspected and eventually found to be hemostatic.The chest was closed and patient was transferred to the icu intubated on high inotropic and vasopressor support andinhaled veletri.

• 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: 14706114
• Report Number: 3005687633-2022-00128
• Device Sequence Number: 12030720
• Product Code: KRH
• UDI-Device Identifier: 08022057013620
• UDI-Public: (01)08022057013620(240)AF-830(17)240622
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• 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,Followup
• Report Date (Section B): 07/14/2022

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: 06/22/2024
• Device Model Number: AF-830
• Device Catalogue Number: AF-830
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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: 72 YR
• Patient Sex: Male