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

Model Number	PVS25
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that a perceval valve size 25mm which was implanted in the patient on (b)(6)2019, was explanted on (b)(6)2023 due to svd.Reportedly, the valve had inter-commissural calcification and reduce leaflets motion.Based on the further information received, hemodynamics post-implant were as follows: mean gradient: 12mmhg, max gradient 22.4mmhg.Furthermore, patient has diabetes type ii, dyslipidemia, conserved ejection fraction, and moderate hypertrophy left ventricle.
Event or Problem Description
The manufacturer was informed that a perceval valve size 25mm which was implanted in the patient on (b)(6) 2019, was explanted on (b)(6) 2023 due to svd.Reportedly, the valve had inter-commissural calcification and reduce leaflets motion.Reportedly, hemodynamics post-implant were as follows: mean gradient: 12mmhg, max gradient 22.4mmhg.Furthermore, patient has diabetes type ii, dyslipidemia, conserved ejection fraction, and moderate hypertrophy left ventricle.Patient is taking adiro 100, vokanamet januvia and crestor 10mg.Based on the further information received, patient went to the emergency room on (b)(6) 2023 due to central thoracic and epigastric pain, along with dyspnea.Ete was perform on (b)(6) 2023 where the perceval l was evidenced in the aortic position.Significant prosthetic dysfunction with gmax 95mmhg, medium gradient 60mmhg.Itv ratio of 0.18 and mild-moderate aortic regurgitation was noted.As such, aortic valve replacement was required.
Additional Manufacturer Narrative
A follow up report will be provided upon completion of investigation and/or receipt of any further information.
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 a manufacture¿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 valve was returned to the manufacturer.Intrinsic and vegetating calcifications are detected in the remnant portions of leaflets.There was pannus overgrowth on the inflow sewing ring of the valve.Nitinol stent results broken in multiple positions.X-rays of the subject valve showed intrinsic calcifications in the remnant portions of leaflets.Histo-morphological analysis was also performed.Intrinsic and vegetating calcifications were detected in all leaflets.Scars and/or mesothelial delaminations were visible where intrinsic calcifications became extrinsic.Fibrous pannus depositions were visible on the crown, on all sinusal struts and along all outflow adherent margins.On leaflet a, at post 1 there was a hole.A large reddish area was visible in the belly.On leaflet b, small thrombus depositions were visible at post 2.On leaflet c, a tear was present at post 1.A large reddish area was visible in the belly.The nitinol stent had several breakages.The localization, combined with the deformation/alteration of the portion of the pericardium, allow us to state that they were reasonably occurred during the manipulation for the explantation of the prosthesis.Histological analyses were performed on samples taken from leaflets a and c.In leaflets a and c, alizarin red s stain showed that the pericardium was thicker than normal because of intrinsic and-or vegetating calcifications.In leaflets a and c, hematoxylin and eosin stain showed that the collagen bundles were disrupted, defibrated and homogenated.Pericardial delaminations were detected on leaflets a and c.Bacteria were not detected with the gram stain.Leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the inflow lumen also contributed to valve stenosis.Aortic insufficiency likely resulted from a probably leaflet tear.As reported in the scientific literature, structural valve deterioration 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 history and risk factors (i.E., diabetes type ii, dyslipidemia, conserved ejection fraction) may have contributed to the structural valve deterioration observed in this perceval s valve.As such, the cause of the event can be related to patient condition.

• 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: 17014975
• Report Number: 3004478276-2023-00151
• Device Sequence Number: 12480854
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)230201
• 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: 2019
• 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,Followup
• Report Date (Section B): 07/05/2023

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: 02/01/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 06/05/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 05/26/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 68 KG