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

Model Number PVS25

Device Problems Material Too Rigid or Stiff (1544); Insufficient Information (3190)

Patient Problem Thrombocytopenia (4431)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device remains implanted.

Event 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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 332898752
• Report Number: 3004478276-2024-00111
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)250302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 61 KG