MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP); HEART VALVE, MECHANICAL

Model Number AP-023

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a patient was intended to receive a carboseal device model ap-023.The device was explanted intraoperatively because during decannulation, it was noticed the conduit was broken; the valve appeared separated from the conduit.Another carboseal was ultimately implanted.The patient was not affected by the event.Per additional information received, it was confirmed that no alterations were identified in the graft at the time of implantation.Once out of the extracorporeal circulation, it is reported that a significant bleeding was noted from the aortic root.It is cannulated through the groin, bypass was restarted and it was identified that the conduit was broken.The valve appeared separated from the conduit (about 2 cm).No complications associated with the procedure were reportedly identified.

Event Description

On (b)(6) 2020, a patient was intended to receive a carboseal device model ap-023.The device was explanted intraoperatively because during decannulation, it was noticed the conduit was broken; the valve appeared separated from the conduit.The patient ultimately received a carbomedics reduced 23mm (r5-023) and a vascutek conduit.The patient was not affected by the event.Per additional information received, it was confirmed that no alterations were identified in the graft at the time of implantation.Once out of the extracorporeal circulation, it is reported that a significant bleeding was noted from the aortic root.It is cannulated through the groin, bypass was restarted and it was identified that the conduit was broken.The valve appeared separated from the conduit (about 2 cm).No complications associated with the procedure were reportedly identified.

Manufacturer Narrative

A complete manufacturing and material records review for the carboseal device model ap-023 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 returned ascending aortic valve prosthesis was received blood stained, with visible traces of removed suturing stitches and a large area of the conduit (almost half portion of the circumference) detached from the valve.After the formalin treatment the visual inspection was performed.Several marks of alteration of the cuff fabric were noticed and can be associated to the use of scissors or scalpel blade, considering the clean-cut appearance, that can be reasonably related to the removal procedure.No structural breakages were observed.The visual inspection of the cuff of the valvular component, showed that the structural element (i.E.Lock ring), dedicated to keeping the outflow portion of the cuff connected to the stiffening ring, had completely come out of its dedicated seat (i.E.Groove in the stiffening ring) although in the absence of breakages.The partial conduit detachment, which caused the massive blood effusion claimed in the event, is not related to a structural break but rather to the complete exit of the lock ring on the outflow side from its dedicated groove.Further testing are ongoing as means of additional investigation on the event and its root cause.A follow up will be provided to this reporting activity upon completion of the investigation.

Manufacturer Narrative

The manufacturer performed additional investigations on the returned product.X-ray was performed in order to document the status and configuration of the components of the returned device.The results clearly showed that the lock ring of the cuff is completely outside and that the lock ring of the conduit is partially outside and for a portion not visible and then reasonably still correctly connected.Removal of the internal orifice was carefully done in order to disassembly the components and document the internal status and configuration in the interface among orifice and other components.On the basis of the analysis conducted on the returned device, it can be seen that the outflow portion (i.E.The one towards the conduit) of the cuff was released from the stiffening ring along the entire conference.The absence of the double layer of fabric and the lock ring, compared to the normal assembly configuration, considerably increases the clearance between the external surface of the orifice and the internal part of the stiffening ring.The aforementioned clearance increase can reduce the capability to retain the conduit bound to the valve prosthesis.In this particular configuration a similar detachment, with consequent massive blood effusion, has to be considered as a very probable event.For this reason, in phase of design verification, specific tests are foreseen with the aim to evaluate the maximum axial load to detach the conduit from the valve.Simulations with the aim to reproduce the configuration observed on the returned device were carried out.Two scenarios have been hypothesized and taken into consideration: non-conformity of the product.It consists of a non-compliantly assembled product: with the cuff ring out of the stiffening and the conduit ring in the wrong groove.Product compliant.The event has been produced during the surgical maneuver likely in inadvertent way.During the simulations performed as a support of the hypothesis a (i.E.Manufacturing defect), a revision of the entire manufacturing process has been carried out in order to verify the existence of potential weak point in the process that could allowed the release of a non-compliant product consistent with the hypothesis a.For this purpose, some specimens have been specially made incorrectly assembly components with the same coupling clearance of the device object of the complaint.Each sample was then subjected to the control steps of the manufacturing procedure (i.E.Torque measurement and visual inspection).Finally, the non-compliant samples were tested with tensile testing equipment and pressure test with water.Based on the simulations performed in the frame of the hypothesis a (i.E.Manufacturing defect), it was possible to demonstrate that, even if a non-compliant product was assembled in the production phase, this would have most reasonably failed the visual inspection and/or raised flags to supervisors during production.Furthermore, based on the additional simulations performed (i.E.Water pressure tests), it was observed that the failure mode is different (i.E.Either it will resist at physiological pressure or a complete detachment is observed when the pressure is significantly higher) than what observed in the returned product (i.E.Partial detachment).Further simulations were performed to investigate on the hypothesis b (i.E.Inadvertent mishandling).The scenarios were simulated with stresses applied to the prosthesis simultaneously.Based on the simulations performed, it was possible to reproduce a mishandling configuration leading to results similar to what was observed on the returned product.Based on the investigations performed, hypotheses a and b, although both are to be considered very improbable, cannot be considered impossible: in fact, it was possible to reproduce the configuration observed on the returned device, following both hypotheses (i.E.Manufacturing defect and mishandling).However, based on the information available and on the results of the simulations of the hypothesis a, showing a different failure mode than what reported from the field, it is possible to conclude that the event reported can be considered most likely resulting from a possible mishandling that was applied in inadvertent way during the implanting procedure, according to the simulations of hypothesis b.Ultimately, a definitive root cause for the reported event cannot be established.

• Brand Name: CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10857131
• MDR Text Key: 216953446
• Report Number: 1718850-2020-01198
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013477
• UDI-Public: (01)08022057013477(240)AP-023(17)221001
• 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: 10/21/2020,04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: AP-023
• Device Catalogue Number: AP-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2021
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention