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

Model Number CPHV

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/04/2018

Event Type  Injury  

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 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.

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.

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
• Type of Device: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7317719
• MDR Text Key: 101646346
• Report Number: 3005687633-2018-00124
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)S1223496-N
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2020
• Device Model Number: CPHV
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 04/13/2018
• Supplement Dates FDA Received: 03/29/2018; 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention