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

Model Number PVS27

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)

Patient Problems Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 08/11/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 a perceval pvs7 was implanted into a patient who needed an avr.A high aortotomy was performed and there was significant calcification of the valve, and the right and left coronary cusps were fused.Extensive debridement was required.The annulus was sized to a 23mm inspiris edwards valve, initially a perceval xl was selected to be implanted.The perceval xl was deployed and looked to be in excellent position and the right and left main coronary arteries were unobstructed.Aggressive deairing was performed and the patient still required some defibrillation, as the patient stabilized a moderate central aortic insufficiency was noted.Cross-clamp was reapplied and a cardioplegic arrest was reperformed.Distortion and a crescent-shaping perceval valve was noted and the valve was explanted.Based on additional information no cpr was performed and the patients annulus was 25mm.

Manufacturer Narrative

The valve was returned for investigation.The visual inspection, performed on the returned prosthesis valve, did not highlight pre-existing defects.The height of the leaflet was verified and was found in compliance with the specifications.The dimensional analysis confirmed the absence of dimensional irregularity, confirming the correct dimensions of the returned device.The replication of collapsing phases was performed using the returned valve pvs 27/xl and an accessory kit demo.No problems were encountered in the collapsing phase, and the replication has been completed with a good result.During the simulation of the valve deployment in silicon aortic roots #25 and #27, no problems were encountered during the ballooning phase: the sealing at the annulus level is guaranteed.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks were observed during both simulations.Considering the static conditions of the test and despite the residual deformation observed at the inflow side level, the water level remained stable under the leaflets free edge, confirming the stability of the positioning and sealing performance.Furthermore, the manufacturing and material records for the perceval heart valve, model #icv1211 , 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 #icv1211) perceval heart valve at the time of manufacture and release.A review of the steady flow test performed at the time of manufacture a release was also performed.The results demonstrate the acceptable opened and closed leaflet performance of the perceval pvs27 sn# (b)(6).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in the device function test procedure at the time of release.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.Given the information received, which reported that aggressive deairing was performed as well as defibrillation, it is possible that these procedural factors contributed to the reported event.On this regard, it should be noted that the following note is included in the perceval valve ifu ''after perceval s implantation, manipulation of the heart and/or of the ascending aorta, if required, should be done gently; [.] these maneuvers may lead to unknown effects on the implanted valve, including displacement and folding.''.

Manufacturer Narrative

Corrected data: h6.The remainder of the information remains unchanged.Updated fields: b4, g3, g6, h1, h2.

Event Description

On (b)(6) 2021, a perceval pvs7 was implanted into a patient who needed an avr.A high aortotomy was performed and there was significant calcification of the valve, and the right and left coronary cusps were fused.Extensive debridement was required.Initially a perceval xl was selected to be implanted.The perceval xl was deployed and looked to be in excellent position and the right and left main coronary arteries were unobstructed.Aggressive deairing was performed and the patient required some defibrillation.As the patient stabilized, a moderate central aortic insufficiency (ai) was noted.Because of this, cross-clamp was reapplied and a cardioplegic arrest was reperformed.Distortion and a crescent-shaping perceval valve was noted, and the valve was explanted.Based on additional information no cpr was performed and the patient's annulus was 25mm.It was reported that the patient needed a larger valve and that is why a perceval valve xl was implanted.However, after the severe aortic insufficiency was noted, it was decided to implant a smaller inspiris valve (exact size not reported).It was confirmed that the distortion of the perceval caused ai and lv distention, leading to the intraoperative explant.

Manufacturer Narrative

The new information received do not change the information previously provided.The conclusions remains unchanged.

• 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: 12436798
• MDR Text Key: 270498653
• Report Number: 3004478276-2021-00246
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)220418
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2019
• 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