MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number R5-025

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Aortic Insufficiency (1715); Embolism (1829)

Event Date 11/09/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a patient with severe aortic stenosis of the bicuspid aortic valve and ascending aorta dilatation, received a carbomedics reduced r5-025 in aortic position.The patient also received an ascending aorta replacement with a dacron conduit jotec 28mm during the same procedure, which was completed without surgical incidents.After declamping the aorta, with the patient still under cardiopulmonary bypass (cpb), the transesophageal echocardiography (tee) showed a regular function of the prothesis (motion of both leaflets, no significant leaks).Upon weaning from cpb, there was a significant clinical deterioration.A new tee was performed in which there was evidence of dysfunctional lv, severely dilated with severe mi and severe intraprosthetic aortic regurgitation.The movement of one leaflet was correctly visualized but not the other.Given this findings, a leaflet block was suspected.As such, the aorta was re-clamped, the dacron graft was opened for exploration of the prosthesis, and it was identified that one leaflet was missing.The prosthesis was removed, the left ventricular cavity was checked without any finding, and a new carbomedics reduced r5-025 was implanted.The procedure was completed uneventfully, the tee showed a good functionality of the new prosthesis and the patient was transferred to the icu.An urgent ct scan was ordered which identified that the leaflet was lodged at the level of the aortoiliac bifurcation.The patient was transferred to the vascular surgery operating room and the leaflet was removed through an open surgery.The retrieved leaflet appeared to be incomplete.Through ct scan images, it was identified that the missing fragment (reportedly including the anchoring area) was housed in the left common femoral artery, but although said artery was surgically reviewed, it was not found.It was decided to perform an arteriography of the left mi and a 'stop' was identified in the anterior tibial artery.In the absence of ischemia data, a conservative attitude was decided.The patient is presently in good conditions, already discharged and asymptomatic.There is no plan at this time for further treatment to remove the missing piece.

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.Further investigation is ongoing.

Manufacturer Narrative

After decontamination the sewing cuff of the returned valve was removed, in order to identify the serial number, and its position, allowing a correct traceability of the valve and its components.The microscope image of the fracture on the left leaflet shows the direction of propagation toward the axis of rotation that is typical failure mode due to an over rotation of the leaflet.The macro picture of the orifice in the pivots area shows a typical mark let by the leaflet once breakage occurred.These features are consistent with the assumption that this damage is due to a manipulation at the explanting procedure.The right leaflet is the real object of the complaint, and just one portion of the broken leaflet was returned.The microscope inspection identifies typical fracture morphology resulting by compression of the leaflet with opposing forces acting on the two surfaces (inflow and outflow) producing a crushing and chipping effect and leaving traces of foreign material.A sem (scanning electron microscope) analysis was then performed, principally on the fracture surface.This analysis documented the morphology of the fracture showing a primary origin of the fracture propagation due to compression when the leaflet was still integer.Furthermore, the backscattering images highlighted presence of chemical elements with high mass.Eds analysis confirmed the metallic nature of these elements.Examination of the fracture surface at varying magnifications revealed it to be free from harmful voids, inclusions or other manufacturing/ material related defects, which would have contributed to the fracturing of the leaflet.Based on the investigation performed, it is possible to conclude that the left leaflet was returned broken due to manipulation during the explanting procedure (not part of the complaint reported on the device).The right leaflet, object of the reported incident, was broken due the propagation of a fracture starting from a point of origin due to contact with metal tools (e.G.Atraumatic forceps) likely inadvertently applied during the handling of the device for implantation.The leaflet, damaged in an undetectable way, worked causing the fracture propagation finally resulting in the leaflet breakage and escaping.Thus, the root cause of the reported event cannot be traced to an intrinsic defect of the product returned.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10963361
• MDR Text Key: 220213864
• Report Number: 1718850-2020-01208
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012791
• UDI-Public: (01)08022057012791(240)R5-025(17)250619
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020,02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R5-025
• Device Catalogue Number: R5-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention