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

Model Number PVF-S

Device Problem Insufficient Information (3190)

Patient Problem Thrombocytopenia (4431)

Event Type  Injury  

Event Description

The manufacturer was informed on a case of severe thrombocytopenia after a perceval plus size s implant.The patient¿s preoperative platelet count was of 152k.After surgery, the platelet count was of 27k platelets dropped down to 15k.The hospital administered deltacortene 50 mg for 5 days and the platelet rose to 20k.Then, the deltacortene dosage lowered to 25 mg, but platelet fell again back to 15k.The patient was administered with platelet pool and immunoglobulins, and the platelets went up to 79k.The patient was discharged on (b)(6) 2021 with a platelet count of 52k.On monday (b)(6) 2021 the ht control and platelets were 49k.No adverse events occurred, no bleeding, no cerebrovascular accident.No hemodynamic issues were reported (no malpositioning, no leaks, no high gradients).

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12751842
• MDR Text Key: 280151857
• Report Number: 3019892983-2021-01030
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2021,11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other