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

Model Number TBD

Device Problem Insufficient Information (3190)

Patient Problem Thrombocytopenia (4431)

Event Type  Injury  

Manufacturer Narrative

Device still implanted.

Event Description

The manufacturer received information about a patient who received a perceval valve (implant date unknown) and that experienced a low platelet count for 2 months.The platelet level is around 10,000.Steroid administration and bone marrow-related treatments have been attempted, but there are no signs of improvement.No further details have been provided to date.

Manufacturer Narrative

Since the device remains implanted and the serial number is unknown, no further investigation is possible at this time.Based on the information available, it is not possible to draw a definitive root cause for the reported 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.Should further information be available in the future, the manufacturer will provide an update to this reporting activity.

Event Description

The manufacturer received information about a patient who received a perceval valve (implant date unknown) and that experienced a low platelet count for 2 months.The platelet level is around (b)(4).Steroid administration and bone marrow-related treatments have been attempted, but there are no signs of improvement.No further details have been provided to date.The manufacturer attempted to retrieve additional information on this event, but the site did not provide any other information.The only update provided is on the patient's conditions, reporting that the patient's thrombocytopenia recovered within the last year (i.E.2021).

• 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: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12682460
• MDR Text Key: 277927266
• Report Number: 3004478276-2021-00269
• Device Sequence Number: 1
• Product Code: LWR
• 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
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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