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

Model Number	CPHV
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6), 2011, a carbomedics standard mitral valve m7-025 was attempted to be implanted, but the surgeon noticed that one of the leaflets was not mobile.The valve was removed and another device of the same valve type and size was implanted.The explanted valve will be returned to the manufacturer.
Additional Manufacturer Narrative
The manufacturer received the device involved in the reported event.The device was returned with a detached and broken leaflet, without the fragment.After decontamination and cleaning, the sewing cuff of the returned valve was removed to identify the serial number.The damaged and disassembled leaflet corresponds to the right leaflet.The results of the microscopic visual inspections performed in the broken leaflet highlighted cracks in along the direction ear-to-ear in both the surfaces and damages due to the contact area and maximum stress area.Those present a morphology typical of the contact between ear and pivot stops after overload applied on the leaflet.In addition, some marks likely correlated to the contact with surgical tools were detected as well.The above-mentioned areas correspond to the location where the maximum tensile stress is applied to the leaflet in a condition when the leaflet is forced to over rotate in the opening direction.Such an over rotating force would likely occur by means of surgical instrumentation or it is the result of a mishandling of the valve with not dedicated accessories.The review of the data contained in the device history record confirmed that the returned carbomedics valve sn (b)(6) satisfied all material and dimensional requirements of a carbomedics standard - model m7-025, at the time of manufacture and release, including a proof/functional test.Based on the investigation performed, it can be concluded that the right leaflet was broken in correspondence of the right back ear with damages areas having morphology typical of over-rotation maneuver.The inspection led to the conclusion that a load, exceeding the ultimate strength of the pyrolytic carbon, was inadvertently applied to the leaflet during the handling of the device for implantation, causing local over loading and torque of the component and finally resulting in the leaflet breakage and escaping.The root cause of the reported event can therefore be traced to an unintended use error.
Event or Problem Description
On (b)(6) 2021, a carbomedics standard mitral valve m7-025 was attempted to be implanted, but after implantation the surgeon noticed that one of the leaflets was not mobile.The valve was removed and another device of the same valve type and size was implanted.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11702072
• Report Number: 1718850-2021-01056
• Device Sequence Number: 3436371
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)230311
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021
• Report Date (Section F): 03/22/2021

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: 03/11/2023
• Device Model Number: CPHV
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: 56 YR