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

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Date 11/22/2016

Event Type  Death  

Manufacturer Narrative

There is no clear link between the device and the patient's death.The manufacturer is reporting this event in a conservatice manner as a death occured.

Event Description

The manufacturer was notified of the following via patient registration: a carbomedics mitral valve m7-025 sn # (b)(4) was implanted and explanted on (b)(6) 2016 at (b)(6) medical center.The surgeon had tried a couple of different valves but ended up with av dissociation and the patient died in the or.

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.Based on internal review of the reported case from the limited information received, there does not appear to be a clear link between the valve and the patient's death.Therefore, the likely cause of the patient's death was due to patient condition and possible risk factors.

• Brand Name: CARBOMEDICS STANDARD MITRAL MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS,
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; via crescentino sn; saluggia, vc
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 6214383
• MDR Text Key: 63605728
• Report Number: 3005687633-2016-00027
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

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: Other
• Device Expiration Date: 02/28/2021
• Device Model Number: CPHV
• Device Catalogue Number: M7-025
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Date Device Manufactured: 03/31/2016
• 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): Death
• Patient Age: 49 YR