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

Model Number	PVS25
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombocytopenia (4431)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device remains implanted.
Event or Problem Description
On (b)(6)2023, a perceval valve pvs25 was implanted in a patient.Blood platelet has decreased right after the surgery and the patient required transfusion.However, the things did not go well.Reportedly, blood platelet was more than 100,000 /l before the surgery, which is under 10,000 /l now.No further information is available at this time.
Event or Problem Description
On (b)(6) 2023, a percival valve pvs25 was implanted in a patient.Blood platelet has decreased right after the surgery and the patient required all types of transfusion.However, the things did not go well.Reportedly, blood platelet was more than 100,000 /l before the surgery, which is under 10,000/l now.Based on the further information received, patient had no symptoms before hospitalization.During hospitalization, paigg antibodies were elevated, and patient was diagnosed with itp thrombocytopenia (which is complicated by myasthenia gravis).As such, treatment was started.Haptoglobin was measured for suspected hemolysis, and the value dropped, leading to suspicion of hemolysis due to artificial valve, but there were no problems with pvl or pressure gradient (no abnormalities in percival function).Cardiopulmonary bypass and cross-clamp time was reported as 111min and 83 min respectively.Reportedly, patient has a history of myasthenia gravis, copd asthma, diabetes, complete atrioventricular block which required ddd pacemaker implanted prior to percival operation.Patient's medications have been reported as: myasthenia gravis medicine, antihypertensive medicine, copd antiphlogistic medicine, diabetes medicine, laxatives.
Additional Manufacturer Narrative
Manufacturer is retrieving and reviewing the products manufacturing records.A follow up report will be provided upon completion of this review or/and receipt of any additional 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 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.Based on the information available, it is not possible to draw a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified with the perceval valve involved in the event.Thrombocytopenia (tcp) in cardiac surgery is a very well-known phenomenon.The etiology is multi-factorial due to multiple factors including hemodilution, blood loss with volume repletion with platelet-poor fluids, platelet activation, consumption and destruction due to contact with foreign surfaces.Tcp following aortic valve replacement (avr) is also a common phenomenon.Patient factors and prolonged extracorporeal circulation all being recognized predictors of tcp following cardiac surgery.

• 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: 18514982
• Report Number: 3004478276-2024-00111
• Device Sequence Number: 7188564
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)250302
• 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: 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): 03/26/2024

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: 03/02/2025
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 01/22/2024; 02/26/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/20/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 61 KG