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

Model Number	PVS23
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event through patient tracking department.Reportedly a patient who received a perceval valve size 23 on 05 dec 2019, is being evaluated for possible tavr due to aortic stenosis.No further information is available.No other allegation of device dysfunction or adverse event on the patient has yet been received from the site.
Additional Manufacturer Narrative
H3 other text : possible tavr.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6.The manufacturing and material records for the perceval heart valve, model # icv1209, 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 # icv1209 perceval heart valve at the time of manufacture and release.Based on the review performed on manufacturing document, no deficiencies with the device were noted.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., dyslipidemia, essential (primary) hypertension, etc.) may have contributed to the structural valve deterioration observed in this perceval s valve.
Event or Problem Description
The manufacturer was informed of the following event through patient tracking department.Reportedly a patient who received a perceval valve size 23 on (b)(6) 2019, is being evaluated for possible tavr due to aortic stenosis.Based on the further information received, patient developed worsening dyspnea and acute diastolic heart failure due to severe aortic stenosis.Patient had surgical bioprosthetic avr (medium perceaval) and mild rca, lad and moderate-severe lcx.Status post cabgx1 with svg-om (2019 n.Carolina).Carotid duplex ((b)(6) 2021) b ica 50-69% stenosis.Aaa duplex ((b)(6) 2021) 4.9×4.6 cm.Ble arterial duplex ((b)(6) 2021) normal pressures, rle popliteal stenosis.Venous duplex ((b)(6) 2021) no dvt, no reflux.Patient had cta aorta with runoff ((b)(6) 2022) infrarenal aaa measures 5.7cm with bilateral iliac dilation, ble popliteal with minimal dilation.Patient had evar ((b)(6) 2022) deployment of 29 mm alto aortic body device with subsequent post dilatation, injection polymer within the graft, placement of left and right iliac limb endograft.Patient had abdominal pain and lower back pain post procedure.Cta aorta ((b)(6) 2022) post evar without leak and was discharged from wbh ((b)(6) 2023) with left sided vision loss.Found to have retinal infarct due to ocular artery occlusion.Ct head ((b)(6) 2023) no infarct pattern.Carotid duplex (b)(6) 2023) b ica 50-69%.Echocardiogram ((b)(6) 2023) lvef=65% with well seated avr and negative bubble study.Neurology recommendation was implant of loop device.Ecg with normal sinus.Reportedly, patient is being worked up for pancytopenia.Furthermore, patient has carotid artery disease, cva, dyslipidemia, essential (primary) hypertension, hypothyroidism, lupus anticoagulation syndrome, peripheral vascular disease, thrombocytopenia, and history of coronary and valvular disease.

• 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: 17714304
• Report Number: 3004478276-2023-00174
• Device Sequence Number: 15140863
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220606
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/10/2023

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: 06/06/2022
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 67 KG