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

Model Number R5-021

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Missing Value Reason (3192)

Event Date 02/24/2020

Event Type  Injury  

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.Additional investigation will be conducted upon return of the device.

Event Description

On (b)(6) 2020 a patient was intended to receive a carbomedics r5-021 reduced aortic mechanical heart valve prosthesis as part of an avr with a concomitant mvr in which an optiform f7-027 was implanted.The manufacturer was notified that first the f7-027 was implanted in mitral position.Then aortic valve was decalcified.Although a 23 mm sizer fit into the annulus, 21 mm carbomedics reduced valve was chosen for the aortic position.Firstly, sutures on left and right coronary cusp side tied and while the site was working on non coronary cusp side, the site realized that one of leaflets was broken.The valve was explanted and the site took out parts of the leaflet which had fallen into the ventricle.The site implanted a 20 mm medtronic ap mechanical valve after carbomedics reduced was explanted.Additional information received from the field indicated the following: what was the delay in the procedure as a result of this issue? the time spent under cross clamp.How were the leaflets broken? was this a result of a procedural issue or were the leaflets broken prior to implantation? the leaflets were broken during stitching the sutures on noncoronary cusp.There wasn¿t any pressure or manipulation on the leaflets by surgeon.Is there any imaging available (pictures) of the valve before implant? no.It was indicated the patient/user was not affected.Can you please confirm this? yes, the patient was not affected.He was stabilized and discharged from the hospital with full recovery.Were forceps used to adjust the valve during the procedure? yes.Were there any issues with the concomitant procedure? no.Why was a seize 21 used when the 23 mm sizer was a correct fit? due to patient mismatch.Any further information you may deem to be relevant no.

Manufacturer Narrative

The manufacturer received additional information identifying the following.The leaflets were broken during stitching the sutures on the non-coronary cusp.There was not note of pressure or manipulation on the leaflets by surgeon.The patient was not affected.They were stabilized and discharged from the hospital with full recovery.Forceps were used to adjust the valve during the procedure.No issues were found with the concomitant procedures.The change in size from a 21 to a size 23 valve was a result of a patient size mismatch.The device was returned to the manufacturer for review on march 24, 2020.We received the valve with a leaflet dislodged from the valve and broken in two parts.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.After decontamination and cleaning the sewing cuff of the returned valve was removed, in order to identify the serial number, and its position, allowing a correct trace-ability of the valve and its components.The broken leaflet corresponds to the left leaflet and was fractured on the back side.Visual inspection showed the fracture can be found where the maximum tensile stress is applied to the leaflet in a condition when the leaflet is forced to over rotate in the opening direction.Such an over rotating force would likely occur by means of surgical instrumentation or it is the result of a mishandling of the valve with fingers or not dedicated accessories.The inspection documented the scheme of the resulting load and contact areas based on the simulation and the effects detected.Then, following the breaking of the left back ear, the broken leaflet escaped from the pivot cavity producing the mark detected close to the left back pivot, and quite reasonably, also in the left front pivot in the opposite direction.The examination of the returned carbomedics valve led to the conclusion that a load, exceeding the ultimate strength of the pyrolytic carbon, was inadvertently applied to the leaflet during the handling of the device for implantation, causing local over loading and torque of the component and finally resulting in the leaflet breakage and escaping.This corresponds with the information received identifying the use of forceps in the procedure as well as the information that identified that the leaflets were broken during stitching the sutures on the non-coronary cusp.The root cause is deemed to be cause traced to user.

• 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: 9884808
• MDR Text Key: 191914571
• Report Number: 3005687633-2020-00109
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)R5-021(17)240415
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: R5-021
• Device Catalogue Number: R5-021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization