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

Model Number PVS21

Device Problems Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Unknown device disposition.

Event Description

On (b)(6) 2021, a perceval valve pvs 21 was attempted to be implanted.The valve was implanted without problems with collapsing.After declamping, during the echo both a central and a pv leak (intermediate position between lcc and ncc) were observed.Th patient was cross-clamped again, the surgeon fine-tuned the valve, and confirmed the correct position and declamped after ballooning at 7 atm.No improvement in the leak was observed via the echo.The patient was cross-clamped one more time and the valve was explanted.Resizing was performed and another pvs 21 size was selected.A new s size valve was collapsed and implanted and a second echo confirmed there were no leaks.The extended cross clamp time was 128 minutes.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, 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 #icv1208) 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 pvs21 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.Since the device was reportedly as not available for return, no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive conclusion for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Based on the manufacturer's experience, procedural factors, such as a device not correct positioning or a device misizing, or patient-specific factors like the presence of bulky calcifications or hypertrophic septum, could contribute to intra-operative events of perivalvular or central leaks.However, since no device investigations was possible and no further information was received, the root cause for the reported event cannot be ultimately stated.The manufacturer has followed up to retrieve additional information on the event.Should any further information be received, a follow up report will be provided.

Manufacturer Narrative

Based on the available information and medical judgement received, the root cause of the event can be traced to the procedure and it is possible to exclude the device as a root cause of the event.From the document review performed, no manufacturing deficiencies were identified in agreement with the surgeons comment that there was no device malfunction noted.Based on the manufacturer's experience, procedural factors, such as a device not correct positioning or patient-specific factors like the presence of bulky calcifications or hypertrophic septum, could contribute to intra-operative events of perivalvular or central leaks.Ultimately based in the surgeon's assessment no relationship between the event and the device was identified as such no further information in warranted and the case is considered close at this time.

Event Description

On (b)(6) 2021, a perceval valve pvs 21 was attempted to be implanted as follows: a small size s was selected by sizing and indwelled without problems with collapsing.After declamped, both central and pv leak (intermediate position between lcc and ncc) were observed moderate or more via echo.Cross-clamped again, fine-tuned the valve, and confirmed the correct position, declamped after ballooning at 7 atm.No improvement in leak was observed via echo.Cross-clamped one more time, the valve was explanted.Resizing was performed and another small size s size was selected.A new s size valve was collapsed and indwelled, and confirmed via echo after declamped.This time, no leak was observed and closed the chest.Extended time of the procedure was about 25 minutes.Midline incision, total cross-clamp time 128 min.Based on the additional information received, the patient was stable during the procedure and there was no issue with the patient's condition.As commented by the surgeon, there was no device malfunction noted and this event occurred due to procedural difficulties and there was no relationship between the device and the event.

• 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: 12443764
• MDR Text Key: 273804992
• Report Number: 3004478276-2021-00249
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230610
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 42 KG