MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. OPTIFORM PROSTHETIC MITRAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	F7-029
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a patient received a carbomedics optiform f7-029 in mitral position.The leaflets were tested after the implant and no issue was identified at that time.At the end of the procedure, normal valve function was observed.However, later in the afternoon, at the ultrasound it was noticed that one of the leaflets was not closing properly thus resulting in regurgitation from the side of the leaflet.It was consequently decided to perform a reoperation.During the re-do surgery, no impediment to the leaflet mobility was identified.The optiform f7-029 was explanted and replaced with a st.Jude valve size 29.The patient's conditions after the re-intervention are reportedly good.Before explanting of the carbomedics valve, the patient had hematuria, and the hematuria disappeared after the valve replacement.
Additional Manufacturer Narrative
The returned device underwent a visual and macroscopic inspections according to procedure.The results confirmed the absence of manufacturing defects.Per internal clinical review of the echo clip provided from the field, regurgitation from the mitral valve was confirmed, but the valve leaflets were both moving.Based on the performed analysis and document review, the reported issue cannot be explained by any factor intrinsic to the involved device.As reported, the device was inspected after the implant and before the explant, and no allegation of malfunction or deficits were reported from the field.It is possible that the procedural context and/or patient factors contributed to the event, although this cannot be ultimately confirmed.The root cause of the event remains ultimately unknown.
Additional Manufacturer Narrative
Fields changed: b4, d10, g4, g7, h1, h2, h6.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, including a funtional test performed on (b)(6) 2019.The device was returned to the manufacturer and it was received on 17 oct 2019.The returned valve was received in generally good conditions with some signs of stitching on the sewing cuff.The leaflets were free to open.Further investigation is ongoing.
Additional Manufacturer Narrative
The manufacturer received additional information clarifying that the re-operation of the patient occurred at the end of the surgical procedure.The patient did not leave the operating room between the first and second mitral valve replacement procedures.The event description in section b5 has been properly updated.
Event or Problem Description
On (b)(6) 2019, a patient received a carbomedics optiform f7-029 in the mitral position.After the implant, the leaflets were tested and no issue was identified at that time.No functional defects were reported and normal valve function was observed.However, during the ultrasound check at the end of the surgical procedure, it was noticed that one of the leaflets was not closing properly thus resulting in regurgitation from the side of the leaflet.It was consequently decided to perform a reoperation immediately.At the time of explant of the device, the leaflet was checked again but no impediment was identified.The optiform f7-029 was explanted and replaced with a st.Jude valve size 29.The patient had a good outcome after the procedure.Before explanting of the carbomedics valve, the patient had hematuria, and the hematuria disappeared after the valve replacement.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9050778
• Report Number: 3005687633-2019-00224
• Device Sequence Number: 16773291
• Product Code: LWQ
• UDI-Device Identifier: 08022057012869
• UDI-Public: (01)08022057012869(240)F7-029(17)240209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060S019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/25/2019

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: 02/09/2024
• Device Model Number: F7-029
• Device Catalogue Number: F7-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 10/15/2019; 11/15/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/03/2019; 11/08/2019; 11/25/2019
• 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