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

Model Number PVS23

Device Problems Collapse (1099); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and stent, model #icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model #icv1209) perceval heart valve at the time of manufacture and release.The manufacturer is following up with the site to retrieve further information regarding this event and the device involved.A follow up report will be provided upon receipt of the device or of any further information.

Event Description

The manufacturer was notified by ansm of an intra-operative explant of a perceval s size m valve occurred on (b)(6) 2023.Reportedly, a deformation of the valve stent was observed upon valve deployment which was not resolved after dilatation with the balloon.As reported, only 15 minutes were added to the surgical time due to this event, with no clinical consequences on the patient.As per additional information received by the manufacturer, positioning difficulties were experienced since the sheath was difficult to shift.No device malpositioning or missizing were identified and the prosthesis was ultimately replaced with a new one of the same size.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.Corrected fields: h6.The valve was returned to the manufacturer for analysis and received on (b)(6) 2023 in acceptable storage conditions.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.A replication of collapsing was performed using the returned valve pvs 23/m and a demo accessory kit, in order to attempt to reproduce the reported event.No problems were encountered in the collapsing phase and the replication has been completed with an acceptable result except for an overlapping of the stent structures observed on the outflow crown.During the simulation of the valve deployment in silicon aortic roots #21 and #23 the stent structure recovered the correct shape without evident macroscopic traces of the deformation previously observed during the collapsing phases.Most probably, the deformations observed on the collapsed valve could be a result of the stress in the stent material induced by the maneuvers performed to release the valve during the operation, since some difficulties were experienced as reported.The observed appearance could also be linked to some deformations occurred, in unperceived way, during the collapsing phases at the time of the operation.No problems were encountered during the ballooning phase and the sealing at the annulus level was guaranteed; thus, the valve remained fixed within the annulus.No paravalvular leaks were observed during the simulation of the static leak test as further confirmation of the stability of the positioning and sealing performance.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.However, it is not possible to exclude the involvement of accessories (i.E.Dual holder) as a cause of the reported release difficulties which may have induced the deformations observed in the valve, which were evident on the deployed valve at the time of the event and perceivable only on the collapsed valve at the time of testing.Since limited information is available on the accessories and the accessories were not returned to the manufacturer, this cannot ultimately be confirmed.

• 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
• 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: 17670665
• MDR Text Key: 323171213
• Report Number: 3004478276-2023-00172
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)261102
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• 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