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

Model Number PVS27

Device Problem Leak/Splash (1354)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 12/01/2022

Event Type  Injury  

Event Description

The manufacturer was informed that on the (b)(6) 2022 perceval valve size xl was implanted in the patient.As reported, the valve was explanted on (b)(6) 2022 due to perivalvular leakage.When the valve was removed, it was noted that the stent was broken in three places.Ultimately, another perceval valve was implanted in the patient.The size of the replacement valve is unknown at this time.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and nitinol stent, model #icv1211, 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 and its component satisfied all material, visual, and performance standards required for a (model #icv1211) perceval heart valve at the time of manufacture and release.

Event Description

The manufacturer was informed that on the (b)(6) 2022 perceval valve size xl was implanted in the patient through upper mini sternotomy.As reported, the valve was explanted on 1 dec 2022 due to severe perivalvular leakage.When the valve was removed, it was noted that the stent was broken in three places.Ultimately, onx 23 mm valve was implanted in the patient through full sternotomy and patient was discharged after12 days.Reportedly, the native aortic valve was tricuspid with severe stenosis and trivial insufficiency.The procedure was isolated procedure miniavr.Patient's annulus was measured as 29 mm in tte.Based on the information received, no intra-operative tte was conducted.Only pre and post implantation was performed.As reported, no positioning difficulties or abnormal geometries in the patient annulus were noted, no further decalcification was performed.Furthermore, no difficulties during the explant of the valve were experienced.

Manufacturer Narrative

Upon visual inspection after sanitization, an area of the pericardium appeared damaged and perforated by the metal frame of the stent.In one place in particular, the structure visibly protrudes through the pericardium.Damaged areas on the pericardium of the leaflet 3 are likely caused by the sharpened edges of the arms of the stent fractured and protruding through the pericardium.Three points of fracture on the sinusoidal elements were also identified.X-rays of the returned valve showed that the inflow crown is fractured in two positions, confirming the correlation of the above mentioned damaged areas on the pericardium and some anomalous shape of the inflow portion of the stent documented also in some pictures received from the field.In order to proceed to a complete and accurate inspection of the nitinol structures, all the pericardium portions of the valve have been carefully removed.No defects or anomalies were detected on the external and internal surfaces of the stent and on all the laser cut surfaces.At this point a thorough inspection of the fracture surface has been carried out by means of both stereoscopic and sem.In general, it is possible to confirm the absence of raw nitinol tube defects, manufacturing defects and in vivo service corroded zones at the fracture initiation point both of the three sinusoidal elements and of the two inflow ring struts.The absence of inclusions in the broken section or absence of manufacturing deficiency in the cutting surfaces, allows to exclude pre-existing defects as possible cause of the breakage.No remarkable traces of contact with surgical tools were observed near to the broken section and then it is possible to exclude mishandling with surgical instruments ad potential cause of breakage.By the analysis of the fracture surfaces, the presence of areas with signs of ductile overload is indicative of strains that are evidently over the ones, foreseeable and permissible deformations by the design, which can occur during the normal in vivo functionality and/or during the collapsing procedure.The different morphologies detected in the different locations are suggesting that the breakages in the two inflow ring struts happened first.The higher presence of ductile behavior in the fracture surfaces is suggestive of a bending occurred likely at the valve collapsing phases.In addition, the plication and altered areas detected on the pericardium skirt, must be considered as evidence of folding with the material very compressed.This geometric shape is more consistent with the configuration that the inflow portion of the valve assumes in the event of folding that occurs during the collapse phase.This event, albeit infrequent, has already been observed in the past and during our simulations.Analyzing the damages observed on the pericardium, on the internal side of the inflow ring, it is possible to highlight that: the part of the structure protruding through the tissue corresponds to the loop just above one of the points of fracture located in the inflow ring struts.The area pierced is reasonably caused by the sharpened extremities of the arms of the stent fractured the load required to pierce and cross the pericardium is quite high and requires an axial direction which, together with its high value, is not compatible with the forces present in vivo at the level of the annulus.Vice versa, this would be consistent with the load applied with the recall of the cap present in the dual holder.Finally, the damaged area on the leaflet surface is reasonably due by contact with the sharpened portion of the broken arms but not in the normal functionality because the leaflet, in the open shape, cannot dilatate in radial direction so much to arrive in contact with the internal portion of the inflow ring.The contact is only possible in the case of folding of the valve once deployed or in collapsed configuration.Even if the first assumption cannot be totally excluded, the second one is in more in line with the scenario previously described.On the basis of the analyses carried out, if on the one hand it is possible to exclude manufacturing defects as a cause of breakages, and furthermore it is possible to argue that the breakages occurred in the presence of overload, but it is not possible to exhaustively identify the sequence of actions produced this overload.

Event Description

The manufacturer was informed that on the (b)(6) 2022 perceval valve size xl was implanted in the patient through upper mini sternotomy.As reported, the valve was explanted on (b)(6) 2022 due to severe perivalvular leakage.When the valve was removed, it was noted that the stent was broken in three places.Ultimately, onx 23 mm valve was implanted in the patient through full sternotomy and patient was discharged after 12 days.Reportedly, the native aortic valve was tricuspid with severe stenosis and trivial insufficiency.The procedure was isolated procedure mini avr.Patient's annulus was measured as 29 mm in tte.Based on the information received, no intra-operative tte was conducted.Only pre and post implantation tte were performed.As reported, no positioning difficulties or abnormal geometries in the patient annulus were noted, no further decalcification was performed.Furthermore, no difficulties during the explant of the valve were experienced.Based on the further information received, the site acknowledged that some difficulties were experienced during collapsing xl size valve compared to smaller sizes.Reportedly, patient is fine and there were no adverse consequences related to the reoperation.

Manufacturer Narrative

Based on the analysis performed, the absence of inclusions in the fracture surfaces and the absence of manufacturing deficiencies in the cutting surfaces, allows to exclude pre-existing defects as possible cause of the breakage.The analysis of the fracture morphology is excluding the in vivo forces as possible cause of breakage, while confirming the large deformations and overloading as the most reasonable causes of failure.As such, it is possible to argue that the breakages occurred in the presence of overload, but it is not possible to exhaustively identify the sequence of actions produced this overload.Thus, the cause of the event can reasonably be attributed to unintended use-error.

• 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16066118
• MDR Text Key: 306316946
• Report Number: 3004478276-2022-00218
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• 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