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

Model Number PVS21

Device Problem Positioning Failure (1158)

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

Event Date 04/18/2022

Event Type  Injury  

Event Description

The manufacturer was informed of following event occurred during a double valve replacement procedure on (b)(6) 2022.First a mitral biological valve (size#27, not corcym product) replacement was performed.Then moved to the aortic valve replacement.The valve leaflets and calcifications were removed and sizing was performed using the s sizer.The brown end of the s valve detector could pass smoothly, and the white end passed with resistance.Thus the pvs21 was selected.Then guiding sutures were placed, valve was collapsed and deployed.Ballooning and other necessary processes were performed.When the aorta was about to be sutured, the valve popped up suddenly.Then the valve was explanted, collapsed one more time, and implanted again.The valve same issue occurred.(implanted time: 10:30 am.Explanted time: 10:40 am).Sizing was performed using m sizer, and perceval s size m (ref.(b)(4)) was selected to be implanted.Reportedly, there was no impact on the patient and patient was in a good condition.Pre-operative ultrasound report showed that the diameter of the annulus was 15mm and the ct measurement was 22mm.Based on the additional information received, sinus canal junction was 26mm and annulus diameter was 22.9mm.The ratio of the sinus canal junction over annulus diameter was 1.13 which was less than 1.3.Pre-operative examination showed the outflow tract stenosis, hypertrophic cardiomyopathy, and atrial fibrillation.The ventricular septum and left ventricular wall were also thickened symmetrically, especially at the base, and the thickest part was 15 mm.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, 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 satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.A follow up report will be provided upon the receipt of the device or further information.

Manufacturer Narrative

Since the device was not returned to the manufacturer, no further investigation on the device can be performed.Since the valve was not returned to the manufacturer for further investigation, the definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies were identified.Based on the information reported (hypertrophic cardiomyopathy, the ventricular septum and left ventricular wall were also thickened symmetrically), it is possible that patient anatomy could have contributed to the reported event, but this cannot be ultimately confirmed.Thus, the cause of the reported event cannot be established.It should be noted that in the perceval s ifu the following has been indicated as a warning: ''the available clinical data indicate that using perceval s in patients requiring multiple valve replacement or repair, or in patients previously implanted with a prosthesis in the mitral, pulmonic or tricuspid position, may result in intraoperative valve misplacement or insufficient leaflet coaptation leading to valve replacement, due to possible interference with the other prostheses.The decision of using perceval s in these patients should be based on a careful individual assessment and limited to cases in which the benefits of using perceval s justify these risks.'' furthermore, it is reported that the valve was attempted to be re-collapsed.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.H3 other text: due to the lock down in china and blood contamination, the device was not returned to the manufacturer.

Manufacturer Narrative

Updated fields: b4, d9, g1, g3, g6, h2, h3, h6.Corrected field: h6 (health effect - clinical code).The device was returned to the manufacturer.The visual inspection, carried out on the returned valves, did not reveal any pre-existing defects.The replication of the collapsing phases was performed using the returned prosthesis pvs 21/s #b11778 and the demo accessory kit.No problems were found in the collapse phase and replication was completed with a good result.During the simulation of the valve deployment in the silicon aortic root #21, no problems were found during the ballooning phase: the sealing at the annulus level is guaranteed as visible in the attached images.The valve remained fixed inside the annulus.Then, inserted some water into the aortic root from the outflow side.No paravalvular leaks were observed during the simulation.Considering the static conditions of the test, the water level remained stable under the free edge of the leaflets.Based on the analysis performed, it is possible to exclude the relationship between the reported problem and the quality of the returned device.Furthermore, from the document review performed, no manufacturing deficiencies were identified.Based on the information reported (hypertrophic cardiomyopathy, the ventricular septum and left ventricular wall were also thickened symmetrically), it is possible that patient anatomy could have contributed to the reported event, but this cannot be ultimately confirmed.It should be noted that in the perceval s ifu following warning has been indicated: ''the available clinical data indicate that using perceval s in patients requiring multiple valve replacement or repair, or in patients previously implanted with a prosthesis in the mitral, pulmonic or tricuspid position, may result in intraoperative valve misplacement or insufficient leaflet coaptation leading to valve replacement, due to possible interference with the other prostheses.The decision of using perceval s in these patients should be based on a careful individual assessment and limited to cases in which the benefits of using perceval s justify these risks.'' furthermore, it is reported that the valve was attempted to be re-collapsed.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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 14414776
• MDR Text Key: 292730041
• Report Number: 3004478276-2022-00149
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)251027
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 72 KG