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

Model Number	PVS25
Medical Device Problem Codes	Calcified (1077); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model #icv1210, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.The manufacturer will submit a follow up report upon receipt of the device or of any additional information.
Event or Problem Description
The manufacturer was informed of an early explant of a perceval s sutureless aortic prosthesis size large.Reportedly, the valve had been implanted on (b)(6) 2021 through right upper hemisternotomy and was explanted and replaced with a mechanical prosthesis from a different manufacturer (sjm regent #21) on (b)(6) 2024.No concomitant surgeries were performed at the time of the initial avr procedure.Reportedly, the re-do surgery was performed with technical success and no intra or post-procedural complications were reported.As per medical judgment received, while no pannus growth was observed, the explanted perceval prosthesis showed an abnormal complete hardening of two of the leaflets, leading to fixed leaflets, and a partial hardening of the third one.As reported, no structural damage was observed on the prosthesis.As per additional information received, the patient had a history of type 2 diabetes mellitus, tablet controlled, hypercholesterolaemia, ischemic heart disease (severe distal lad disease), fibromyalgia, oesophagitis, anxiety/depression and had heart failure symptoms, breathless on minimal exertion, prior to the re-do surgery.
Additional Manufacturer Narrative
The manufacturer has received the device for analysis on july 15th, 2024 and evaluation is ongoing.The manufacturer will submit a follow report upon completion of the investigation or if any new information is received.
Additional Manufacturer Narrative
Note: medical device problem code has been updated based on the results of the investigation.The explanted perceval valve was returned to the manufacturer for investigation.The valve was stored in an unknown solution inside a specimen jar, with an amount of preservation liquid that appeared insufficient to properly cover the prosthesis during transport.The gross examination revealed prosthetic stenosis due to intrinsic calcifications in all three leaflets.The stent and the skirt were covered by fibrous pannus that on the inflow side protruded 2-4mm into the lumen, narrowing the annulus, and contributing to stenosis.All the leaflets were almost stiff due to intrinsic calcifications.Scars were visible where intrinsic calcifications became extrinsic.Dark areas and/or material depositions due to incorrect prosthesis preservation were visible near the outflow free edges of all leaflets and on all outflow posts.A histological analysis was performed which confirmed that leaflet thickening was due to large intrinsic calcifications.Fungi infiltration was detected throughout the samples reasonably due to incorrect prosthesis preservation.There were no signs of endocarditis.Folds were observed in all three leaflets due to their altered movement.Based on the analysis performed, it is possible to confirm that the observed leaflet hardening was due to leaflets calcification, which caused stiffening and led to progressive valve stenosis.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).Based on literature data, it is reasonable to assume that the patient¿s clinical conditions and risk factors, specifically coronary artery disease, diabetes mellitus and hypercholesterolemia, have played a major role in the early structural valve deterioration observed in this perceval s valve.It should also be noted that, as per information received, a st jude regent size 21 mechanical prosthesis was implanted as a replacement valve.Dimensional analysis suggests that the perceval valve was oversized, leading to an altered kinematics that has reasonably further accelerated the calcific degeneration of the prosthesis.Ultimately, it should be considered that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• 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: 19727820
• Report Number: 3004478276-2024-00151
• Device Sequence Number: 11563235
• Product Code: LWA
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)241118
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 08/27/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/18/2024
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/20/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/01/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 115 KG