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

Model Number	CPHV
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 05 feb 2021, a carbomedics optiform prosthesis f7-033 was intended as part of a mitral valve replacement procedure.The patient¿s pre-operative diagnosis was of mitral valve endocarditis.After exposure of the mitral valve, the anterior leaflet was excised, while the posterior leaflet and the subvalvular apparatus were preserved.The prosthesis was implanted in anti-anatomical position.After weaning from bypass, the prosthesis functionality was checked at the transesophageal echocardiogram (tee) and an intermittent blockage of the posterior leaflet of the prosthesis in the close position was detected.The cross-clamp was re-started, and the valve was checked.The inspection of the prosthesis did not find the cause of the leaflet blockage.There was no residual cord that could interfere with the opening of the valve.The threads were cut flush.The mobility of the leaflets with the tester appeared normal.The prosthesis was rotated to the anatomical position.After de-clamping, the prosthesis was checked again at the tee and an asynchronous mobility of the leaflets was detected with a new blocking when closing the rear leaflet.The valve was ultimately explanted and replaced with another carbomedics optiform prosthesis f7-031 (another f7-033 was not available).The procedure was completed, and a good functionality of the new prosthesis was conformed.The patient underwent a prolonged surgery, but a good outcome is reported and will be discharged soon.
Additional Manufacturer Narrative
The device involved in the reported event was returned to the manufacturer for investigation.The gross examination performed on the returned prosthesis highlighted the presence of some suture stitches still present on the valve; the sewing cuff appeared slightly blood stained.The valve appeared with the leaflets freely moving in both fully open and closed positions after the completion of the sanitization and cleaning treatment, the device was visually inspected to verify the compliance of the product with the manufacturing specifications.Several traces of needle passage / suture stitches, according with the suture procedure, were observed and the more evident of them have been identified.The sewing cuff was then removed to identify the serial number, and its position, allowing a correct traceability of the valve and its components.In order to allow an exhaustive evaluation of the functional behavior, the subassembly of the returned cphv underwent hydrodynamic testing in simulated physiological conditions.The test confirmed a normal leaflet kinematic showing a correct movement of the leaflets; no anomalies were observed during the open/close cycle of the pulsatile hydrodynamic test in both normotensive and hypotensive pressure conditions.Furthermore, 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.Based on the investigation performed, no manufacturing deficiencies have been identified and no functional anomalies were observed during the open/close cycles recorded during the kinematic tests.Based on clinical experience and data from the literature, phenomena of partial leaflet immobilization that could induce opening difficulty could be caused by entrapment between the leaflets and the housing of long suture tails, prosthesis size mismatch, suboptimal valve orientation and peculiar hydraulic conditions in the heart.Ultimately, based on the information available, a definitive root cause cannot be established at this time.However, no mechanical malfunction could be reproduced during the investigations performed and no manufacturing nor quality deficiencies were identified in the returned valve.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 11429731
• Report Number: 3005687633-2021-00099
• Device Sequence Number: 3539485
• Product Code: LWQ
• UDI-Device Identifier: 08022057012883
• UDI-Public: (01)08022057012883(240)F7-033(17)240809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060/S019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: CPHV
• Device Catalogue Number: F7-033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR