MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP); HEART VALVE, MECHANICAL

Model Number AP-023

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Information (3190)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

Device currently being returned.

Event Description

On (b)(6) 2018 a carboseal ap-023 mechanical aortic heart valve prosthesis was implanted.It was reported one of the leaflets was stuck.The device is being returned for analysis thus intra-operative explant is assumed but no confirmation has been received.

Event Description

Submitted with initial report.

Manufacturer Narrative

A gross and visual inspection was performed on the returned device.The returned material was received packaged in the original carton box, contained in a plastic blister in dry conditions.All the returned material was received in general good conditions except for the cut on the conduit and some blood stains on the cuff of the device.No traces of blood on the conduit surfaces.In particular the leaflets appeared freely moving.The visual assessment on the device, performed after the decontamination, did not reveal evidences of the completion of the suturing procedure: possible stitches but without traces of knotting and their subsequent removal.The polyethylene conduit was then carefully removed and the identification number engraved, on the outer surface of the housing was detected.The visual inspection performed on the cphv subassembly didn¿t show any macroscopic anomalies: no remarkable traces of foreign material were detected in the hinge cavities, as possible explanation of the reported leaflet blockage, confirming the leaflets free movement.A hydrodynamic test was performed to verify device functionality.The hydrodynamic testing conducted on the cphv subassembly, size 23 ¿ s1261817-b was performed.The effective orifice area (eoa) at 70 bpm, 5 l/min of cardiac output and mean backpressure of 100 mmhg is 1.76 cm2 , well above the iso 5840 minimum requirement (1.25 cm2 ).The valve showed correct movement of the leaflets during opening / closure phases and no anomalies were observed in hypotensive conditions.The result of the device history record review of the prosthesis sn: (b)(4) confirmed that the returned product satisfied all material, dimensional and performance standards required for a carbomedics carbo-seal - ascending aortic prosthesis ap023, at the time of manufacture and release, including the subassembly function test performed on october 11, 2016.It has to be considered that the carbo-seal is supplied already mounted on its handle and the device ifu (ic0215007016_rev.H), at paragraph ix "directions for use", indicates, ¿the preattached handle must not be removed from the device until after the prosthesis has been sutured in the tissue annulus.Although direct handling of the graft portion of the device may be necessary during the implantation procedure, manipulation of the gelatin-impregnated graft material should be minimized to avoid compromising the sealed properties of the device.After final orientation of the valve in the patient annulus, leaflet mobility may be assessed with the aid of the "leaflettester".Considering the above mentioned ifu indications and investigation results, it is not clear when and for what reason the handle was removed and how the leaflet mobility test was performed.In general, one of the possible causes of the leaflets blockage could be associated with the presence, on the cphv subassembly surfaces, of some gelatin particulate, which can migrate from the conduit graft at the moment of the implant, in cases of a manipulation.This is one of the reasons for the ifu warnings.Nevertheless, the returned device did not present foreign material on the hinge cavities and the reported stuck behavior was not observed.Based on these results the reported incident cannot be specifically attributed to any factor intrinsic to the device and the exact root cause of the event cannot be determined at this time.However, the incident can be regarded as a failure to follow the instructions for use.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP)
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7584513
• MDR Text Key: 110569947
• Report Number: 3005687633-2018-00164
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013477
• UDI-Public: (01)08022057013477(240)AP-023(17)200430
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

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: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: AP-023
• Device Catalogue Number: AP-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention