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

Model Number	CPHV
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is trying to obtain further information about the event.Further investigation will be reported in follow up report.Device disposition not presently known.
Event or Problem Description
Manufacturer was notified that at the time of surgery, while rotating the valve, the leaflet was damaged and was dislodged.The device was replaced.
Additional Manufacturer Narrative
The manufacturer was unable to obtain additional information about this event, and the valve was not received for analysis.As such, no investigation can be performed at this time, and the root cause of the event cannot be determined.Should additional information be obtained in the future, appropriate investigative actions will be taken.Device not returned.
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.

• Brand Name: MECHANICAL HEART VALVE PROSTHESIS
• Common Device Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7317719
• Report Number: 3005687633-2018-00124
• Device Sequence Number: 16170578
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)S1223496-N
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2018

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: Health Professional
• Device Expiration Date: 09/21/2020
• Device Model Number: CPHV
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/09/2018; 04/13/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/29/2018; 04/13/2018
• 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