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

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Thrombosis (2100); No Information (3190)
Date of Event	02/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2020 a patient received a carbomedics optiform f7-027 mechanical heart valve as part of an mvr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a carbomedics standard m7-031 mechanical heart valve.No further information was received.
Additional Manufacturer Narrative
On (b)(6) 2020 a patient received a carbomedics optiform f7-027 mechanical heart valve as part of an mvr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a carbomedics standard m7-031 mechanical heart valve.The manufacturer received additional information from the site identifying the following.The optiform thrombosis occurred in the context of apparently therapeutic inr (2.5).At the time of reoperation, the device was covered in a thin film of pale white thrombus (possibly fibrin).This was completely cleaned off in situ so the leaflets could be tested and freely mobile without restrictions.Following neutralization of the heparin with protamine, the device clotted off again in the operating room.Returned back on pump with heparin and replaced the mitral valve with a standard device (larger size).No issues this time.Patient is alive and well with thrombosis service aiming for higher inr.(pt was a double valve case with aortic valve replacement done at initial surgery).Pathology identified thrombus on device.No mechanical comments made.It was identified by the patients family that the patient never bruised as a child from injuries and the site suspected a procoagulant state that was not clearly identified, hence why the patient has been quickly anticoagulated post-operatively.
Event or Problem Description
On (b)(6) 2020 a patient received a carbomedics optiform f7-027 mechanical heart valve as part of an mvr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a carbomedics standard m7-031 mechanical heart valve.The manufacturer received additional information from the site identifying the following.The optiform thrombosis occurred in the context of apparently therapeutic inr (2.5).At the time of reoperation, the device was covered in a thin film of pale white thrombus (possibly fibrin).This was completely cleaned off in situ so the leaflets could be tested and freely mobile without restrictions.Following neutralization of the heparin with protamine, the device clotted off again in the operating room.Returned back on pump with heparin and replaced the mitral valve with a standard device (larger size).No issues this time.Patient is alive and well with thrombosis service aiming for higher inr.(pt was a double valve case with aortic valve replacement done at initial surgery).Pathology identified thrombus on device.No mechanical comments made.It was identified by the patients family that the patient never bruised as a child from injuries and the site suspected a procoagulant state that was not clearly identified, hence why the patient has been quickly anticoagulated post-operatively.
Additional Manufacturer Narrative
Based on the additional information received the valve displayed no mechanical issues or relationships to the event.The thrombosis was hypothesized to be a result of patient related factors.As such no further investigations will be performed at this time.The conclusion of the manufacturers analysis is thus cause cannot be traced to device : adverse event related to patient condition.

• Brand Name: CARBOMEDICS OPTIFORM PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 9914536
• Report Number: 3005687633-2020-00113
• Device Sequence Number: 16332424
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)230211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2020

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: 11/02/2023
• Device Model Number: CPHV
• Device Catalogue Number: F7-027
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 06/01/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/23/2020; 06/01/2020
• 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: 60 YR