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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/28/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs21 implant attempt occurred.After de-clamp, perivalvular leakage (mild-trace) was observed, so the device was explanted and perceval m size was implanted.The cross-clamp time was 37 minutes for implanting the perceval size s, and 33 minutes for implanting perceval size m.There seems to be no effect on the patient.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and stent, model #icv1208, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve and component satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Further investigations are ongoing.

Manufacturer Narrative

Fields updated: b4, g3, g6, h1, h2, h6.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications.The height of each leaflet was checked using the specific tool and led to compliance.The dimensional analysis confirmed the correct dimensions of the returned device.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.Based on the manufacturer's experience, intraoperative events of perivalvular leak can be secondary to a device malpositioning or a device mis-sizing.Given that in this case it is reported that the perceval valve pvs21 was replaced with a perceval valve pvs23, the root cause of the reported event can be reasonably traced to a device mis-sizing (use error).

Manufacturer Narrative

The manufacturer received additional information as reported in b5.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.Based on the medical judgment received, the root cause of the reported event was attributed to the device mis-sizing (use error).No device malfunctions occurred and there was no patient adverse impact.As such, no further investigation is warranted at this time.

Event Description

On (b)(6) 2021, a perceval valve pvs21 implant attempt occurred.After de-clamp, perivalvular leakage (mild-trace) was observed, so the device was explanted and perceval m size was implanted.The cross-clamp time was 37 minutes for implanting the perceval size s, and 33 minutes for implanting perceval size m.There seems to be no effect on the patient.Based on the medical judgment received, the root cause of the perivalvular leak was attributed to the valve mis-sizing (no stent folding, no malpositioning occurred).As reported, there was no device malfunction.The patient remained stable during the procedure and had a good outcome.

• 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: 12707241
• MDR Text Key: 281983884
• Report Number: 3004478276-2021-00270
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230911
• 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,Followup
• Report Date: 12/02/2021

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 Expiration Date: 09/11/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 10/29/2021; 11/29/2021
• Supplement Dates FDA Received: 11/26/2021; 12/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2020
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 44 KG