MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVF-M

Device Problem Incomplete Coaptation (2507)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/07/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a perceval plus valve size m was attempted to be implanted.Reportedly, during the echo, a central leak was noted.Furthermore, surgeon discovered ncc cuspid side leaflets were not coaptating.As such, decision was made to explant and re-implanted the valve.However, central leak was still present in the echo imaging.Thus, the valve explanted again.The procedure was completed with a conventional valve, medtronic avalus.After the surgery, the surgeon examined the explanted pvf-m and found that one of the leaflets on the ncc side leaflets is shorter than the other sides.Based on further information received, there was no malfunction identified prior to this event and no mis-sizing was identified.As reported, the procedure was combined coronary artery bypass grafting and aortic valve replacement (cabg-avr), and the patient geometries were not considered abnormal.Patient¿s annulus size was 21mm, and there was no additional debridement or annular restructuring performed prior to the second implant.The procedure was delayed by about one hour.The patient has been in stable condition throughout the procedure and no patient effects have been reposted.

Manufacturer Narrative

A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 3.9 % and it is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in both normotensive and hypotensive conditions regarding the total and full coaptation of the leaflets.Although a leaflet (i.E.The leaflet #1) appears with an anomalous shape in the relaxed configuration, it is important to highlight that this configuration does not appear either in the images documenting the open/close test, nor in the images documenting the tests performed in the pulse duplicator in hypotensive / normotensive conditions.The observed anomalous shape can be more likely associated to some small undetected deformations that occurred during implantation / explantation or possible non-optimal storage conditions before returning the prosthesis to corcym.However, the observed feature is totally unrelated to the coaptation problem complained of by the customer, which, on the contrary, is probably due to the patient's peculiar anatomy.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because the claimed issues were not observed during the investigation carried out (i.E., hydrodynamic test).It is possible that the patient's peculiar anatomy has contributed to this event.But since limited information is available in this regard, this cannot ultimately be confirmed.Should further information be received in the future, the manufacturer will provide a follow up report.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16531625
• MDR Text Key: 311208393
• Report Number: 3005687633-2023-00101
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)251212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• 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
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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