MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVS21
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : will not be returned by site.
Event or Problem Description
The manufacturer was notified of an intra-operative explant of a perceval s sutureless aortic bioprosthesis.The event occurred during an avr surgery performed through full sternotomy on a patient suffering from endocarditis and aortic insufficiency grade iii-iv.Reportedly, a size s was deemed appropriate and fitted perfectly into the annulus.Ballooning was performed according to the valve¿s ifus.As reported, severe regurgitation was experienced after closing the aorta, both in the form of central and paravalvular leak.The regurgitation was attributed to a distortion of the upper ring of the perceval stent, caused by the compression exerted by the sinotubular junction, which was particularly narrow.No diagnostic images were shared with the manufacturer for analysis.As per additional information received, the perceval valve was replaced with a conventional sutured bioprosthesis from a different manufacturer (st jude medical/abbott epic supra 19mm).Root enlargement was performed to accommodate the replacement valve and bentall procedure plus 2 venous anastomoses (to lad and rca) was also needed.The event led to a significant prolongation of surgery time, with 190 mins of cross clamp and by pass time added to the procedure, during which an instability of the patient was experienced.According to the medical judgement received, no malpositioning of the perceval valve was observed and the stent deformation occurred because of the specific anatomy of the patient (narrow sinotubular junction) which could have been possibly prevented with more accurate preoperative planning.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve and stent, model #icv1208-eu, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacture¿s quality engineering.The results confirmed that this valve and its component have been manufactured and controlled in accordance with the specifications for a (model #icv1208-eu) perceval heart valve at the time of manufacture and release.Since the device was not returned to the manufacturer, no further investigation could be performed on the event and the prosthesis involved.From the information retrieved, it should be noted though that a root enlargement was needed to accommodate the valve which was ultimately implanted in the patient.Comparing the sizing tables for the two valves, it is possible to conclude that the patient's annulus was too small to accommodate the perceval valve, thus confirming the hypothesis that compressive forces exerted by surrounding anatomical structures led to the observed stent deformation reported in this case.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, vercelli V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18254736
• Report Number: 3004478276-2023-00209
• Device Sequence Number: 7191531
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)250728
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/17/2024

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: 07/28/2025
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• 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: 11/04/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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: Required Intervention
• Patient Sex: Unknown