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  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(4), including the nitinol stent component, as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Based on the available information and medical judgment received, the root cause of the reported event of intraoperative perivalvular leak can be attributed to the device mispositioning (use error).No device malfunctions reportedly occurred with the perceval valve involved as commented by the surgeon.As such, no further device investigation is warranted at this time.It is reported that the malpositioning may have been caused by the severe calcification at the left ventricular outflow tract.However, it is unknow if further decalcification was performed before the implant of the second perceval valve of the same size.The manufacturer is following up to retrieve additional information, but no further details on the event and patient's impact have been received to date.Should further information be provided in the future, a follow up report will be provided.No device malfunctions reported per medical judgment, no investigation necessary.

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.

Manufacturer Narrative

Fields updated: b4, b5 (new summary provided following the receipt of additional information), g3, g6, h1, h2.There is no change to the coding previously provided in section h6.The root cause previously provided remains unchanged: based on the available information and medical judgment received, the root cause of the reported event of intraoperative perivalvular leak can be attributed to the device mispositioning (use error).No device malfunctions reportedly occurred with the perceval valve involved as commented by the surgeon.As such, no further device investigation is warranted at this time.

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.Per additional information received, it was confirmed that no further decalcification was performed after the explant of the first valve and the implant of the second perceval valve.Furthermore, it was reported that the patient remained stable during the procedure and that there was no adverse event caused by 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
• 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: 13077859
• MDR Text Key: 286337240
• Report Number: 3004478276-2021-00293
• 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: 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: 02/10/2022

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 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
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2020
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 55 KG