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

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem No Information (3190)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

This event was followed by a second adverse event that has been reported in a second emdr.The only information available regarding the device in question was that the event was related to a "sorin mitral valve".Follow-up with sales revealed that the failure to rotate the device occurred due to inadequate proctoring.As such, the event is attributable to a training deficiency.Device not available for return.

Event Description

The manufacturer became aware of this event during follow-up for a case reported via patient tracking: on (b)(6) 2017 an attempt was made to implant a sorin mitral valve.After an intra-operative tee, the physician tried to turn the valve, but was not successful and decided to place a new one.The valve was subsequently explanted.The delay in the procedure due to the event is unknown.Additional information received from sales revealed that the event was the result of inadequate proctoring regarding the device in question.

• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 6984170
• MDR Text Key: 90450720
• Report Number: 3005687633-2017-00110
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• 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
• Patient Age: 44 YR