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

Model Number PVF-L

Device Problems Malposition of Device (2616); Difficult to Open or Close (2921)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval plus valve pvf-l was attempted to be implanted as follows: a size large perceval plus was deployed in the annulus but one commissure tipped up at the non coronary cusp after ballooning.The valve was removed and could not be recollapsed properly again using same accessory kit.It was decided to open a new perceval plus large which was collapsed with no problems using existing collapser and holder.Again the valve was tipped up after ballooning so it was removed, recollapsed and this time snare sutures were used for the guiding loops to ensure valve did not move.The valve was successfully implanted.

Manufacturer Narrative

The device was returned to the manufacturer for investigation.After decontamination of the valve, a visual inspection was performed according to the procedure at the time of manufacture and release.The results of the visual inspection confirmed the absence of macroscopic anomalies and/or pre-existing, except a deformation visible on the pillar corresponding to the first post#1.The deformation can be considered consistent with the reported case history (i.E.''valve stent was damaged when pulling the stent during the explant'').In order to allow an exhaustive evaluation of the functional behavior, a replication of collapsing was performed using the returned valve and a demo accessory kit.No problems were encountered with the positioning the returned valve in the dual collapser and during the collapsing phases.The result of the collapsing replication can be considered acceptable despite the deformation observed and documented in the pillar of the post#1.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.The root cause of the reported device malpositioning can be traced to the patient's anatomy based on the medical judgment received.In addition, the collapsing difficulties experienced in the attempt to re-collapse the valve were attributed to the damages applied to the stent when pulling the stent during the explant.Furthermore, it is useful to point out that the valve had been correctly collapsed at the first attempt.It should be noted that the percival valve instructions for use state that: ''a removed percival prosthesis must not be re-implanted, because its integrity is no longer ensured.''.As such, the decision to re-collapse the valve was made off-label.

Event Description

Based on the additional information received, the valve ''tip-up''/displacement was attributed to the patient¿s anatomy per the surgeon¿s assessment received.The valve tilting was realized after the deployment, while the patient was still on bypass.Regarding the collapsing difficulties experienced with the first valve, the surgeon reported that it appears that the valve stent was damaged when pulling the stent during the explant.This was believed to be the cause of the re-collapsing difficulties noted with the valve.The procedure was prolonged (exact time unknown) but the patient remained stable with no adverse consequences reported after the procedure.One accessory kit was used for the whole procedure (with both valves and for all attempts of collapsing).The remainder of the information previously submitted remains unchanged.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-l, s/n # (b)(6), 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 #pvf-l) perceval plus heart valve at the time of manufacture and release.The device returned to the manufacturer for investigation.A supplemental report will be provided upon completion of the investigation.

• Brand Name: PERCEVAL PLUS 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: 12516551
• MDR Text Key: 277683165
• Report Number: 3004478276-2021-00255
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)220506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• 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: 11/23/2021

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 Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 10/22/2021; 11/22/2021
• Supplement Dates FDA Received: 11/20/2021; 11/23/2021
• 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