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

Model Number CPHV

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem Thrombosis (2100)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

Device history record review and mechanical evaluation of the device will be conducted.Not returned to manufacturer.

Event Description

The company was notified on (b)(6) 2015 about an issue related to a carbomedics standard mitral valve (model m7-029, (b)(4)).On (b)(6) 2015, the d.M.V.(b)(6) patient, implanted a valve.On (b)(6) 2015 the patient returned to the hospital to re-operate the valve due thrombosis on the valve.The patient was re-operated to remove the prosthesis and replacement with another.

Manufacturer Narrative

The review of device history records confirmed that the prosthesis sn (b)(4) satisfied all material, visual, and performance standards required for a m7-029 (b)(4) standard mitral valve at the time of manufacture and release.The visual inspections performed on the returned valve confirmed the absence of manufacturing defects.No information about the patient's risk factors and the post-operative inr patient's regimen were provided from the hospital.In the present case, no explanation for the reported event can be given on the basis of the lack of information received from the field.

• Brand Name: CARBOMEDICS STANDARD MITRAL MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: giovanni bergamasco ; via crescentino sn; saluggia, vc 13040 ; IT 13040 ; 9161487034
• MDR Report Key: 5252960
• MDR Text Key: 32235410
• Report Number: 3005687633-2015-00007
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/14/2018
• Device Model Number: CPHV
• Device Catalogue Number: M7-029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 48 YR