MAUDE Adverse Event Report: CORCYM CANADA CORP. SOLO SMART STENTLESS HEART VALVE; TISSUE HEART VALVE

Model Number TBD

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Aortic Valve Stenosis (1717); Thrombocytopenia (4431); Thrombosis/Thrombus (4440)

Event Date 12/22/2021

Event Type  Injury  

Event Description

The manufacturer was informed about an event of solo smart valve explant that occurred in (b)(4) 2021.The device was implanted 3 years ago.Thrombocytopenia has continued immediately after implantation.In the latest check up, aortic valve stenosis (peak jet velocity 3.6 m / s) were also observed, thus the device was explanted on (b)(6) 2021.A large amount of thrombus have been adhered to the cusps of the explanted device.Therefore, they presumed that aortic stenosis (as) symptom was observed.The cusps and parts of the aortic side of the device were excised, then inspiris valve was implanted.

Event Description

On (b)(6) 2018, aortic valve replacement was performed using solo smart 21mm.Simultaneously, mitral valve replacement (epic 27mm) was performed for mitral regurgitation, and maze operation for atrial fibrillation.The platelet count, which was 100000 to 150000 before surgery, decreased to 50000 to 80000 at the time of discharge.Since then, the patient has been examined in the hematology department.Examinations such as bone-marrow biopsy were performed, however no obvious abnormal findings were found.On (b)(6) 2021, a rapid thrombocytopenia (50000 or less) and large amount of thrombus in the left atrium were observed, and thrombectomy was performed at cardiovascular surgery department.In the preoperative evaluation of this operation, the peak aortic jet velocity regarding aortic stenosis was 3.6m/s, so redo avr with inspiris 19mm was also performed.The post operative course was generally good, however the platelet count remained low at 10000 to 20000, regular platelet transfusion was required.On (b)(6) 2022, the patient was discharged from the hospital, and visited as an outpatient in the hematology department, however the patient suffered from gastrointestinal bleeding and was admitted to the same department.The patient had markedly lowered red blood cells and white blood cells as well as platelets and was diagnosed with aplastic anemia by bone-marrow biopsy.The patient is currently hospitalized in the hematology department and has begun chemotherapy.Patient has chronic arterial fibrillation and hyperlipemia.On (b)(6) 2021, the hit antibody was negative.At the first operation and reoperation, red cell transfusion, frozen plasma transfusion and platelet transfusion were performed.Prior to the reoperation, no anticoagulant therapy was given and the patient had inr 1.0.After reoperation, the patient is controlled inr 1.5 to 2.5 with warfarin medication.Patient was using statin medication until reoperation.After reoperation, bisoprolol and warfarin were added.Pathology test on the valve showed a mild thrombotic adhesion, without significant tissue destruction, and partial resection.The pathology findings were as follow: the leaflets are 20 x 11 mm, 18 x 12 mm, 18 x 8 mm respectively, and the concave surface (aortic side) is glossy and smooth.A mild brownish area is observed on the aortic root side, suggesting thrombus adhesion, which has been pointed clinically.Overall, no significant destruction of the structure was seen and no calcification was observed.No significant inflammatory cell infiltrate.On the surface side of the calve, there is a localized and mild hyperplasia of histiocytes and stromal cells that may be derived from the host, and a slight fibrin-based thrombus adhesion (residual) is observed.Histochemically, the masson-trichrome stain positive layered sequence is generally preserved.There are few elastic fibers that are positive for evg stain.Pas positive substances are scarce.As reported, the cause of thrombocytopenia was difficult to identify from the tissue.

Manufacturer Narrative

Since the device did not returned to the manufacturer and the serial number is unknown, no further investigation can be performed on the device.Since there is no evidence of the device malfunction, it can reasonably be concluded that the patients clinical history and risk factors could have contributed to the reported thrombosis and thrombocytopenia event.As such, the root cause of the event is deemed to be patient related.Given that the platelet count of the patient stayed low even after the explant of the valve and implant of a new valve, the solo valve could reasonably be ruled out as a possible cause of the event.Should any further information be received in the future, the manufacturer will take further investigative actions and update the reporting activity as applicable.H3 other text: device was under evaluation in the hospital and not returned to the manufacturer.

• Brand Name: SOLO SMART STENTLESS 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: 13293596
• MDR Text Key: 284978864
• Report Number: 3004478276-2022-00116
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/19/2022

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: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 03/20/2022
• 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