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

Model Number	PVS25
Medical Device Problem Codes	Calcified (1077); Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Insufficient Information (4580)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified that a perceval s sutureless aortic bioprosthesis pvs25 was implanted on (b)(6) 2018 was explanted on (b)(6) 2023 due to early degeneration.As reported, the device was replaced by a surgical sutured bioprosthesis from a different manufacturer (magna ease size 25).
Additional Manufacturer Narrative
The manufacturer is following up with the site to retrieve further information regarding this event and the device involved.A follow up report will be provided upon receipt of any further information.
Event or Problem Description
The manufacturer was notified that a perceval s sutureless aortic bioprosthesis pvs25 implanted on (b)(6) 2018 through full sternotomy was explanted on (b)(6) 2023 due to early degeneration.As reported, the device was replaced by a surgical sutured bioprosthesis from a different manufacturer (magna ease size 25) with a good outcome.No concomitant procedures were performed at the time of initial surgery.Reportedly the patient presented the following risk factors and medical conditions: diabetes type ii, hypertension, periferal vascular pathology, plus cad, stable angina neoplasia more than 1 year at the time of initial surgery.Patient underwent pacemaker implant in 2021.The following data on device functionality are available to the manufacturer, which show elevated gradients since the immediate post-op: discharge: ppg 32 mmhg ; mpg 16 mmhg 3 month fu: ppg 24.8 mmhg, mpg 11.9 mmhg 1 year fu: ppg 29.8 mmhg, mpg 14.9 mmhg, eoa 1.5 cm2, mild mitral regirgitation, ef 56% trace of central leak were reported at discharge, which were not detected in any of the following fu.A follow up was performed at 2 years (16-04 2020) through phone call and patient was assessed to be nhya class i with no events reported.As per additional information received, patient presented with dyspnoea / shortness of breath and chest pain.Echo showed severe aortic stenosis (max pg 90 mmhg, ava 0.88 cm2) with normal left ventricular function and no aortic insufficiency, reportedly, no signs of malpositioning or mis-sizing of the perceval valve were noticed.Perioperative inspection of the explanted prosthesis showed a calcified valve, mainly at the commissural sites.
Additional Manufacturer Narrative
Updated fields: a2, a3, b4, b5, g3, g6, h2, h3, h6.Corrected fields: b3, b5, d6b.The manufacturing and material records for the perceval heart valve and stent, 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 has been manufactured and controlled in accordance with the specifications for a (model # icv1210) perceval heart valve at the time of manufacture and release.The valve was returned to the manufacturer for analysis.Gross examination revealed prosthetic stenosis due to intrinsic and vegetating calcifications in all three leaflets and x-ray analysis confirmed large intrinsic calcifications in all leaflets.A histo-morphological analysis was performed.The tops of 2 of the posts were found to be covered by fibrous pannus that grew on the free edges of leaflets and contributes to stenosis.All the leaflets were stiff due to intrinsic and vegetating calcifications.Scars and/or mesothelial delaminations were visible where intrinsic calcifications became extrinsic.Fibrous pannus depositions were visible on the crown, on all sinusal struts, on both sides of the skirt, on both sides of all posts and along all outflow adherent margins.The mesothelial surface of one of the leaflets was locally wrinkled.Bacteria were not detected with the gram stain.From the analysis performed, leaflets calcification was detected with visual, x-ray and histological analyses, which caused stiffening and led to progressive valve stenosis.There was no evidence of endocarditis in the returned valve.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).It is possible that the patient¿s clinical conditions and risk factors (i.E.Hypertension, diabetes type ii) may have contributed to the structural valve deterioration observed in this perceval s valve.

• 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
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 17369171
• Report Number: 3004478276-2023-00166
• Device Sequence Number: 17886998
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)210203
• 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: 2018
• 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): 09/19/2023

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
• Device Expiration Date: 02/03/2021
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2017
• 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: 73 YR
• Patient Sex: Male