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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs21 was attempted to be implanted.The preoperative ct scan showed an aortic valve diameter of 20 mm and st junction diameter of 23 mm.The s-sizer white obturator did not pass through stj and valsalva.When the size was confirmed again with reference to the transparent obturator of s-sizer, it was confirmed that the annulus was large enough for the white obturator to pass through.Perceval size s was selected and the product was implanted.No abnormality was observed visually at the time of implant.After implanting, echocardiography showed pvl between the left coronary cusp and the commissure strut.Pvl was closer to mild than trace.Echo showed that it was difficult to see due to noise and artifacts, but the indwelling position seemed to be a little high, so the device was removed.After removal, sizing was performed after checking around the annulus, another perceval size s was placed.Echo after reimplantation showed that there was no problem with the indwelling position and no regurgitation, and the surgery was completed.The doctor commented that the malposition of the device may be related to severe calcification at the left ventricular outflow tract, and there was no malfunction of the 1st pvs device.The x-clamp time was extended by 44 minutes due to this event.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 13077724
• MDR Text Key: 284867928
• Report Number: 3019892983-2021-01056
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)231206
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2021,12/23/2021

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 Expiration Date: 12/06/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2021
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 55 KG