MAUDE Adverse Event Report: LIVANOVA CANADA CORP PERCEVAL SUTURLESS AORTIC HEART VALVE; TISSUE HEART VALVES

Device Problem Folded (2630)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Due to limited information, this event is being reported in a conservative manner.The manufacturer is currently in the process of receiving further information from the physician on this event.Manufacturing site is unknown as the serial number is not yet known.Livanova (b)(4) is listed for this report for the manufacturing site but could also be the sister site , sorin group (b)(4).Device manufacture date and date of expiry is unknown as sn# is not yet known.Not yet determined if device available.

Event Description

The manufacturer was notified on (b)(6) 2017 that a perceval valve experienced stent folding, no further information has been provided at present.Livanova (b)(4) is in the process of gaining further information from the physician on this event.

Manufacturer Narrative

Multiple attempts have been made by the manufacturer in contacting the physician to gather further information on this event.No further information has been provided.The device is not available for return or analysis, nor is the serial number known.No further investigation can be completed at this time.Manufacturing site is unknown as the serial number is not known.(b)(4) is listed for this report for the manufacturing site but could also be the sister site , (b)(4).Device manufacture date and date of expiry is unknown as sn# is not known.Device not returned to manufacturer.

• Brand Name: PERCEVAL SUTURLESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6675724
• MDR Text Key: 78664343
• Report Number: 3004478276-2017-00122
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P150011
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician Assistant
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• 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