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

Model Number	CPHV
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.
Event or Problem Description
A mitral valve replacement was performed, and a carbomedics optiform valve was implanted.After implanting the valve, the leaflet mobility was aassessed with a tested and appeared normal; however, during weaning from bypass, the valve leaflets were not moving, as observed by echocardiography.After converting to bypass once more, the valve was observed to be in the closed position.When the leaflet was rotated, it started opening.The chest was then closed and the operation was finished.It was reported that there was no protruding tissue or chorda tendinea around implanted area, which could inhibit normal valve mobility.It was further stated that the size 29mm valve was appropriate for the patient, and the valve was not over-sized.The patient outcome was good, however the surgery was prolonged as a result of the event.The extent of the delay was not reported.
Event or Problem Description
A mitral valve replacement was performed, and a carbomedics optiform valve was implanted.After implanting the valve, the leaflet mobility was aassessed with a tested and appeared normal; however, during weaning from bypass, the valve leaflets were not moving, as observed by echocardiography.After converting to bypass once more, the valve was observed to be in the closed position.When pushed with the tester, the leaflets moved.When the leaflet was rotated, before weaning from bypass, the leaflets were observed to be mobile.The chest was then closed and the operation was finished.It was reported that there was no protruding tissue or chorda tendinea around implanted area, which could inhibit normal valve mobility.It was further stated that the size 29mm valve was appropriate for the patient, and the valve was not over-sized.The patient outcome was good, however the surgery was prolonged as a result of the event.The extent of the delay was not reported.
Additional 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.As the device was not received for analysis, no further investigation can be performed.However, it is a widely recognized phenomenon that mitral valve rotation is important for the optimal functioning of mechanical valves.The event can reasonably be attributed to improper rotation and alignment of the mitral valve axis, given that the valve was observed to function after it was rotated.Based on the information available, it is reasonable to conclude that the event was attributable to user error.

• Brand Name: CARBOMEDICS 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, vc 13040 ; IT 13040
• MDR Report Key: 7492778
• Report Number: 3005687633-2018-00150
• Device Sequence Number: 160407
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)200126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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
• Operator of Device: Physician
• Device Expiration Date: 01/26/2020
• Device Model Number: CPHV
• Device Catalogue Number: F7-027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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