MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVS23
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
The manufacturer was informed of a perivalvular leak after implant of perceval sutureless aortic heart valve, pvs23/size m.The valve was implanted on (b)(6) 2021.As reported, they are planning to improve paravalvular leak by interventional treatment, such as place an occluder or dilation again with a balloon.Based on the information received, severe paravalvular leak appeared but the time is unknown.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6.
Event or Problem Description
The manufacturer was informed of a perivalvular leak after implant of perceval sutureless aortic heart valve, pvs23/size m.The valve was implanted on (b)(6) 2021.As reported, surgeons were planning to improve paravalvular leak by interventional treatment, such as place an occluder or dilation again with a balloon.Based on the information received, severe paravalvular leak appeared but the time is unknown.Reportedly, the valve was explanted, and magna ease valve was implanted in the patient as a replacement.The exact explant date is unknown.Based on the medical judgment received, the valve was bicuspid type 0.Based on the information received, surgeons don¿t think that this was a product issue.No further information was provided.
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.
Event or Problem Description
The manufacturer was informed of a perivalvular leak after implant of perceval sutureless aortic heart valve, pvs23/size m.The valve was implanted on (b)(6) 2021.As reported, they are planning to improve paravalvular leak by interventional treatment, such as place an occluder or dilation again with a balloon.Based on the information received, severe paravalvular leak appeared but the time is unknown.Based on the information received, the valve was explanted, and magna ease valve was implanted in the patient as a replacement.The exact explant date is unknown.Based on the medical judgment received, the valve was bicuspid type 0.
Additional Manufacturer Narrative
Conclusion will remain the samee.
Additional Manufacturer Narrative
Based on the information available, definitive root cause of the reported event cannot be established but based on the medical judgement received, there was no issue with the device and the event was not device related.Furthermore, from the document review performed, no manufacturing deficiencies were identified.As such, the cause of the reported event cannot be traced to the device.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15388473
• Report Number: 3005687633-2022-00136
• Device Sequence Number: 14879889
• Product Code: LWR
• UDI-Device Identifier: 08022057014702
• UDI-Public: (01)08022057014702(240)ICV1209(17)230909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/07/2023

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: 09/09/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 09/16/2022; 09/23/2022; 02/07/2023; 02/07/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/14/2022; 10/21/2022; 02/07/2023; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Male