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

Model Number ART25SMT

Device Problem Degraded (1153)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Manufacturer Narrative

H3 other text : not explanted, v-in-v procedure.

Event Description

Manufacturer was informed of the following event through publication "a case of a transcatheter valve-in-valve implantation using balloon expandable valve for failed solo smart stentless bioprosthetic valve" by tamura h.Et.Al.Reportedly, a patient who had undergone surgical aortic valve replacement with the solo smart stentless bioprosthetic valve 25 mm and mitral valve replacement with mosaic 29 mm 4 years ago, was diagnosed with congestive heart failure.Echocardiography revealed severe aortic regurgitation caused by degraded bioprosthetic valve.As reported, patient required continuous dobutamine administration to maintain hemodynamics.It was decided to perform transcatheter valve-in-valve implantation (viv-tavi) using balloon expandable valve (edwards sapien 3).Since solo smart stentless valve was placed to valsalva sinus at the supra-annular level with continuous sutures, it was planned to anchor tavi valve 4 mm to the left ventricular side from the bottom of the failed stentless valve.Two pigtail catheters were placed at the bottom of the failed stentless valve leaflet to mark the nadir of stentless valve.After viv-tavi, the patient no longer required catecholamine administration and was discharged home one month later.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18822929
• MDR Text Key: 336733065
• Report Number: 3004478276-2024-00117
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ART25SMT
• Device Catalogue Number: ICV1264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 67 KG