MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on this event through the device tracking department.Based on the information reported on the patient implant form, a carbomedics top hat aortic heart valve s5-021 was implanted on (b)(6) 2010 and explanted on (b)(6) 2022.No further information is presently available.The manufacturer has not received any allegation of a device malfunction nor of serious injury from the site regarding this event.
Additional Manufacturer Narrative
Unknown disposition.
Event or Problem Description
The manufacturer was informed on this event through the device tracking department.Based on the information reported on the patient implant form, a carbomedics top hat aortic heart valve s5-021 was implanted on (b)(6) 2010 and explanted on (b)(6) 2022.No further information is presently available.The manufacturer has not received any allegation of a device malfunction nor of serious injury from the site regarding this event.Per additional information received, the cause of explant of the top hat valve was attributed to subvalvular pannus with obstruction.No device malfunctions were reportedly identified.The device is reportedly not available for return.From the operational report received, it was noted that the patient was admitted for heart failure (chronic systolic heart failure).During the re-do surgery, the top hat valve was noted to be densely adherent to the annulus.There was no indication of previous endocarditis at the annular level.Eventually, the valve was dissected free.Extensive annular debridement was then performed, including removal of the sub annular pannus.The implant of the new valve (s5-021) occurred uneventfully.The patient tolerated the procedure well, there were no complications.The manufacturer was also informed that ultimately the patient passed away on (b)(6) 2022 (due to non cardiovascular causes, event not valve-related).
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, no further investigation was possible and a definitive root cause for the reported event cannot be stated.However, from the document review performed, no manufacturing deficiencies were identified.Prosthetic valve dysfunction at the aortic position is commonly caused by pannus formation, an inflammatory response generally relating to the patient's condition.The exact etiology of pannus formation is not known, but many factors can be involved in its formation.Pannus represents a bioreaction to prosthetic valves associated with coexisting factors such as surgical technique, thrombus organization from inadequate anticoagulation, infection and wall shear stress.As no investigation could be performed, the root cause of the event cannot be confirmed; however, given the reported information confirming the absence of device malfunctions in the top hat valve in question, the event is likely attributable to patient's factors.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• 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: 13592505
• Report Number: 3005687633-2022-00103
• Device Sequence Number: 5761392
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)150703
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 03/17/2022

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: 07/03/2015
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2010
• 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: 77 YR
• Patient Sex: Female