MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL OPTIFORM PROSTHETIC MITRAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device cannot be returned.

Event Description

On (b)(6) 2020, a patient was intended to receive a carbomedics optiform valve f7-025 in mitral position.During the procedure, a potential leaflet dysfunction was identified during the suturing of the valve (i.E.Leaflet reportedly "stuck") and the device was ultimately removed.A new valve of the same model f7-025 was implanted and the operation was successfully completed.It is reported that the leaflet functionality was tested with the dedicated leaflet tester provided.There was no impact for the patient, who performs and recovers well.

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 device was initially made available for return, but not yet received by the manufacturer.Based on the available information, it is not possible to draw a definitive conclusion on the reported event and suspected leaflet malfunction.However, from the document review performed no manufacturing deficits were identified.Should the manufacturer receive any relevant additional information, the case will be re-assessed and a follow up will be provided to the competent authority.

Manufacturer Narrative

Corrected typo error in the conclusion sent previously: based on the performed analysis, the reported issue cannot be related to the device quality.No pre-existing defects were identified in the analysis performed and no functional anomalies were observed during the open/close cycles recorded during the kinematic tests.It is not possible to exclude a possible leaflets impingement / interference with anatomical components (papillary muscles or chordae tendineae).The remainder of the information previously submitted remains unchanged.

Manufacturer Narrative

The returned valve was received with the cuff slightly rotated and blood stained.The leaflets were able to move from the totally closed to the open position.After the formalin and the hypochlorite treatment, the inspections performed on the returned valve confirmed the absence of manufacturing defects.The sewing cuff was then removed to verify the correct traceability.The serial number etched on the orifice is congruent with the one indicated from the field (i.E.Subassembly 1466650).The hydrodynamic testing conducted on the cphv subassembly #25 of the valve f7-025 ¿ sn (b)(6) -a was performed.The valve showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed both in hypotensive and in normotensive conditions.Based on the performed analysis, the reported issue cannot be not related to the device quality.No pre-existing defects were identified in the analysis performed and no functional anomalies were observed during the open/close cycles recorded during the kinematic tests.It is not possible to exclude a possible leaflets impingement / interference with anatomical components (papillary muscles or chordae tendineae).

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10802000
• MDR Text Key: 215287870
• Report Number: 3005687633-2020-00147
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012845
• UDI-Public: (01)08022057012845(240)F7-025(17)250106
• 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,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: F7-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention