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

Model Number PVS27

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problems Thrombocytopenia (4431); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs27 was implanted in aortic position.The device was explanted on 24 oct 2021 due dislodged aortic valve.The patient ultimately received a 25 mm carpentier-edwards valve.No cpr or other manipulation of the heart were performed after the perceval valve implant.The patient was discharged to home on 31 oct 2021.The device functionality was checked at the time of implant, and postoperatively, with the following findings.From the operational note, it is reported that the valve functioned well with mild periprosthetic leak in the expected location of severe calcification.The intraoperative tee post-bypass showed that a well seated bioprosthetic aortic valve.There was no prosthetic valvular regurgitation and mild-moderate perivalvular regurgitation was present.In the midesophageal aortic valve short axis view this was noted by where the native right coronary cusp and the native right-left cusp junction would lie anatomically.In the midesophageal long axis view, the perivalvular regurgitation was noted along where the valve abuts the interventricular septum.No holodiastolic reversals were noted with pulse wave doppler in the descending thoracic aorta.The mean prosthetic aortic valve systolic gradient was 11.3 mmhg.On 23 oct 2021, the echo showed significant paravalvular ar, difficult to quantify but likely in the moderate to severe range.Furthermore, the patient's postoperative course was complicated by thrombocytopenia, in rate controlled atrial fibrillation, acute oluguric renal failure.The patient¿s pre-operative platelets count was 211k, drop to 63k on 15 oct 2021 without bleeding.The platelets count dropped to 23k on (b)(6) 2021, but started to recover on (b)(6) 2021.The patient had no hematological disorders and tested negative for heparine induced thrombocytopenia on (b)(6) 2021.

Event Description

On (b)(6) 2021, a perceval valve pvs27 was implanted in aortic position.The device was explanted on (b)(6) 2021 due dislodged aortic valve.The patient ultimately received a 25 mm carpentier-edwards valve.No cpr or other manipulation of the heart were performed after the perceval valve implant.The patient was discharged to home on (b)(6) 2021.The device functionality was checked at the time of implant, and postoperatively, with the following findings.From the operational note, it is reported that the valve functioned well with mild periprosthetic leak in the expected location of severe calcification.The intraoperative tee post-bypass showed that a well seated bioprosthetic aortic valve.There was no prosthetic valvular regurgitation and mild-moderate perivalvular regurgitation was present.In the midesophageal aortic valve short axis view this was noted by where the native right coronary cusp and the native right-left cusp junction would lie anatomically.In the midesophageal long axis view, the perivalvular regurgitation was noted along where the valve abuts the interventricular septum.No holodiastolic reversals were noted with pulse wave doppler in the descending thoracic aorta.The mean prosthetic aortic valve systolic gradient was 11.3 mmhg.On (b)(6) 2021, the echo showed significant paravalvular ar, difficult to quantify but likely in the moderate to severe range.Based on the medical judgment received, there was nothing wrong with the perceval valve and the valve dislodgment was attributed to operator error.The surgeon chose the perceval valve for the benefits of ease of implant which favored the approach of getting in and out quickly for this frail patient.In retrospect, the patient¿s sinuses were larger than normal and the chosen valve may not have had the radial strength to keep it from dislodging (given the unusual sinus anatomy).Furthermore, the patient's postoperative course was complicated by thrombocytopenia, in rate controlled atrial fibrillation, acute oluguric renal failure.The patient¿s pre-operative platelets count was 211k, drop to 63k on (b)(6) 2021 without bleeding.The platelets count dropped to 23k on (b)(6) 2021, but started to recover on (b)(6) 2021.The patient had no hematological disorders and tested negative for heparine induced thrombocytopenia on (b)(6) 2021.The patient received 3 units of plts and 2 units of prbc on (b)(6) 2021.The patient's tcp was resolved upon discharge, as the plt count was 251,000 on (b)(6) 2021.Renal failure was not resolved upon discharge, but it does continue to improve.

Manufacturer Narrative

The device involved in the reported event was returned to the manufacturer for investigation.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The height of each leaflet was checked using the specific tool and led to compliance.A dimensional verification was performed, and the results showed absence of dimensional irregularity, confirming that the returned valve meets the dimensional specifications required for a model pvs 27/xl valve.In order to allow an exhaustive evaluation of the functional behavior, a simulation of collapsing, deployment and ballooning phases was performed.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 and the valve remained fixed within the annulus.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks were observed during both the 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.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.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality, in agreement with the medical judgment received.The root cause of the reported event can be traced to patient factors as also indicated by the surgeon¿s assessment (i.E.Unusual sinus anatomy).

Manufacturer Narrative

Fields updated: b4, b5 (new information received), g3, g6, h1, h2.

Event Description

Based on the medical judgment received, there was nothing wrong with the perceval valve.The surgeon chose the perceval valve for the benefits of ease of implant which favored the approach of getting in and out quickly for this frail patient.In retrospect, the patient¿s sinuses were larger than normal and the chosen valve may not have had the radial strength to keep it from dislodging (given the unusual sinus anatomy.).

• 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: 12869582
• MDR Text Key: 282107388
• Report Number: 3004478276-2021-00279
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)240317
• 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: 12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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 Sex: Male