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

Model Number PVS23

Device Problems Positioning Failure (1158); Insufficient Information (3190)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

This case refers to the 1st valve not implanted.A second medwatch was submitted for the second valve used.

Event Description

The manufacturer was informed that on (b)(6) 2021 an issue had occurred when implanting a perceval valve.Three perceval valves were used for this procedure, and the third one was successfully implanted.No further information is available on the reason for the failure of implant of the first two valves.The patient was stable throughout the procedure.No adverse outcome for the patient was reported.

Manufacturer Narrative

The returned material was received in two explant kits and one plastic bag.The two valves (related to this report id and to report id: 3004478276-2021-00295) were returned in plastic sample jars filled with an unknown liquid.Both were altered in their morphology apparently due to dehydration despite the presence of liquid.It may reasonably be due to poor storage conditions prior to shipment.The accessories were received in a plastic bag and appeared in good general conditions.Two dual holders were received (related to this report id and to report id: 3004478276-2021-00295), but it was not indicated which one was used first and which one as second.Thus, in order to identify them in the following investigation, they had been called ''a'' and ''b''.Importantly, the dual holder called ''a'' was found with the cap torn off, and the dual holder named ''b'' was found stained with blood.The returned dual collapser was stained with blood but in good condition.After decontamination, the visual inspection performed on the returned prostheses confirmed an inadequate storage condition of the valves, as they appeared dehydrated reasonably due to inadequate storage conditions prior to shipment.In order to attempt to replicate the reported event, a replication of collapsing phases was performed using a pvs 23/m demo valve and the returned accessories (dual holder and dual collapser).No problems were found with the placement of the demo valve in the dual collapser, and no difficulties were observed during the collapsing phase.Both the outflow crown and the inflow skirt were collapsed and properly captured by the holder regardless of the combination a or b.Based on the investigation performed, no abnormalities were observed during the collapse and release of the simulations.Given the state of the returned valves, no further investigation was possible on the prosthesis involved in the reported event.Thus, it is not possible to state a definitive conclusion for the returned valves about their involvement in the reported event, and the root cause of the reported event (i.E.Improper valve positioning) cannot be definitely stated.Regarding the collapsing difficulties reported for this valve s/n # (b)(6), it should be noted that no collapsing difficulties occurred during the first valve collapsing, and that the difficulties were reported only at the time of re-collapsing after the explant.On this regard, as explained in the perceval valve instructions for use, ''a removed perceval 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.

Manufacturer Narrative

H1 corrected (wrongly inputted in the fu#2).

Event Description

The manufacturer was informed that on (b)(6) 2021 an issue had occurred when implanting a perceval valve model pvs23.Three perceval valves of the same size were used for this procedure, and the third one was successfully implanted.This case refers to the first valve used (the second valve is captured in medwatch id: 3004478276-2021-00295).As reported, the surgeon implanted the first valve but had an issue with the inflow ring popping out of position at the point of the non coronary sinus.The surgeon removed the valve and asked the nurse to re collapse it.The nurse attempted to re collapse it but had a problem with the outflow portion of the stent not collapsing down enough.A decision was made to get a new valve and a new set of accessories, but this second attempts failed as well.The surgeon removed it again and asked for a new valve.The nurse got a new valve of the same size of the previous two and new accessories again.The third valve was finally implanted fine with no problems.As reported, there were no issues with the deployment of the valves (i.E.No issues with releasing the valves from the dual holder).In addition, no further decalcification or additional surgical technique was used between the implants.The surgeon was not able to comment on the definitive relationship between the event and the devices involved, but commented that the patient¿s annulus was rather oval shaped and wondered if the patient anatomy was the cause of the issues.The patient was stable throughout the procedure and did not suffer any adverse event during or following the procedure.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model # icv1209, 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 #icv1209) perceval heart valve at the time of manufacture and release.The device is in process of being returned to the manufacturer.Further investigation will be performed upon receipt of the device.Based on the description of the event, it is reported that an attempt to recollapse the same valve was performed.As explained in the perceval instructions for use, "a removed perceval 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.

• 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: 13084373
• MDR Text Key: 284979051
• Report Number: 3004478276-2021-00294
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• 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
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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