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 08 oct 2021 with a platelet count of 52k.On monday 11 oct 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).

Manufacturer Narrative

Device remains implanted.

Manufacturer Narrative

Since the device serial number was not provided and the device remains implanted, no investigation is possible at this time.The manufacturer attempted to retrieve additional information on this event, but no further information has been received to date.Based on the available information, it is not possible to establish a definitive root cause for the reported event.As reported, there was no hemodynamic issue and no malfunctions with the device were identified.There are several non-valve related factors, including complications associated with cardiopulmonary bypass or heparin-induced thrombocytopenia, which cannot be excluded as possible contributing causes.Furthermore, the patient's clinical history may have contributed to the reported event.However, given that the patient's clinical history was not provided, this cannot be ultimately confirmed.The root cause of the event and the relationship to the device remain unknown.If additional information is received in the future, a follow up report will be provided as deemed applicable.

• 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
• 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: 12751877
• MDR Text Key: 281984077
• Report Number: 3004478276-2021-00271
• 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: 12/20/2021

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
• 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
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 12/20/2021
• 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
• Patient Sex: Female