MAUDE Adverse Event Report: CORCYM CANADA CORP. SOLO SMART STENTLESS HEART VALVE; TISSUE HEART VALVE

Model Number ART25SMT

Device Problems Degraded (1153); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

A solo smart valve (size: unknown, sn: unknown) was explanted due to leaflet tear in (b)(6) 2021 (exact date: unknown).The device was implanted 3 - 4 years ago at another hospital.The surgeon suspected that there was problem during ligation considering the position of the tear.No further information was provided at this time.

Manufacturer Narrative

The device involved in the reported event was returned to the manufacturer for investigation.The returned valve was received without storage liquid and almost in dry conditions.The prosthesis appeared quite deformed.After the sanitization treatment, the prosthesis was visually inspected, also by means of stereoscopic microscope.Although a full visual inspection according to the manufacturing procedure could not be possible due to the returning conditions of the valve, it is possible to exclude the presence of macroscopic pre-existing defects in the returned prosthesis.The 3rd leaflet appears bent or pinched and the 2nd leaflet is torn along the seam of the semi-finished product.Despite it is not totally possible to exclude the non optimal storage conditions as possible cause of deformation (i.E.For the reduced dimension of the jar), it is quite reasonably that this folded area has to be correlated to the surgical procedure at the time of the implantation.There are some morphological aspects in the shape and appearance of the deformed pericardium, that can be considered the evidence that the corresponding leaflet worked in such configuration.It results in a ''frozen'' effect of the shape as it appeared to our observation.In addition, it could have induced the overload in other part of the leaflets, in particular in correspondence of the suture line that anchors the functional pericardium sheet (the one of the leaflet) to the structural portion that is sutured to the aorta wall or to the native annulus.Based on the results of the analysis conducted, it is possible to confirm the comment received from the field: ''the surgeon suspected that there was problem during ligation considering position of the tear.'' furthermore, the manufacturing and material records for the solo smart heart valve, model #icv1264, 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 satisfied all material, visual, and performance standards required for a (model #icv1264) solo smart heart valve at the time of manufacture and release.Based on the information available and investigation performed, the root cause of the reported event can be traced to a non-optimal anchorage of the valve during the implantation (cause of the folded area) that led to a progressive damage of the functional parts (tears on the leaflets).No elements of non conformity were identified during the manufacturing and quality documents reviewed, and during the valve inspection.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity.

Event Description

A solo smart valve model art25smt was explanted due to leaflet tear in (b)(6) 2021.The device was implanted in another hospital on (b)(6) 2017.The surgeon suspected that there was problem during ligation considering position of the tear.The manufacturer requested additional information but was informed that no further details will be provided on this event.

• Brand Name: SOLO SMART STENTLESS 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: 12930964
• MDR Text Key: 282106876
• Report Number: 3004478276-2021-00285
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130011
• 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: 02/07/2022

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: 08/07/2020
• Device Model Number: ART25SMT
• Device Catalogue Number: ICV1264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2016
• 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