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

Model Number PVS27

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

Further information has been requested from the physician by the manufacturer-limited information is known to date including device sn# tbd.Please note that this event occurred in (b)(4) and the serial number is not yet known the device may have been manufactured at livanova (b)(4) corp as listed in this report or manufactured at our sister site - sorin group (b)(4) perceval sutureless aortic heart valves manufactured at our sister site are not sold in usa.Device not returned to manufacturer.

Event Description

On (b)(6) 2017 a perceval size 27 was explanted after approx 2 years implant duration due to dislodged valve.The device was implanted in 2015 via mini-sternotomy in a patient with a native bi-cuspid annulus.Once the perceval valve was explanted a carpentier size 23 was then implanted.The surgeon noted that a possible over-sizing may have attributed to the event.

Manufacturer Narrative

The patient outcome has been provided (the patient is doing well).Ince the explanted device (perceval size 27) was retained by the hospital and since no serial number was identified, no investigation is going to be performed by the manufacturer.Based on the explanting surgeon judgment and based on the size of the device implanted when perceval valve was explanted (carpentier size 23) it can be concluded that the root cause of this event could be related to a valve oversizing at the time of implant.

Event Description

Update received on dec.14 2017: the patient is doing well.

Manufacturer Narrative

The manufacturer was notified of the following additional information via the editorial of the following publication: dislocation of a sutureless prosthesis after type i bicuspid aortic valve replacement chiariello g.A., villa e., messina a., troise g., j.Thorac.Cardiovasc.Surg.2018 156:2 (e87-e89).The editorial comment was written by michael carrier (replacement of bicuspid aortic valve with sutureless bioprosthesis: a word of caution here, j thorac cardiovasc surg 2018;156:e91): the editorial comment suggested the patient's bicuspid annulus as a possible contributing root cause of the event.It was reported that the prosthesis "the perceval sutureless bioprosthesis was originally designed for a normal annulus, albeit decalcified in part, with appropriate sinotubular junction and normal sinuses of valsalva.Positioning of the 3 nadir guiding sutures at 120 degrees in asymmetric cusps and redirecting radial pressure of the sutureless prosthesis on the annulus may be difficult in some cases." the author further reported that the "take-home message is that replacement of bicuspid and aortic valve with asymmetric annulus should be performed with standard sutured prostheses.Currently, sutureless and rapid-deployment prosthesis must be reserved for patients with circular annulus and symmetric sinuses." the additional information received suggests that the patient's bicuspid annulus may have contributed to the event.The manufacturer acknowledges that this may have been a contributing factor to the reported event.The additional information does not alter the state of the investigation, or warrant further investigation, as the serial number remains unknown and the device was not received for analysis.Based on the additional information received, the patient's bicuspid annulus may have been a contributing factor in this event.As indicated in the perceval instructions for use, avr with perceval is contra-indicated in patients with bicuspid congenital aortic valve.The ifu therefore clearly addresses this risk.Nevertheless, given that over-sizing of the device was confirmed, and based on the physicians judgement at the time of the event, the root cause of the event remains attributable to over-sizing.

• Brand Name: PERCEVAL SUTURELESS 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
• MDR Report Key: 6980167
• MDR Text Key: 90338596
• Report Number: 3005687633-2017-00108
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2018

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: Physician
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 12/14/2017; 07/23/2018
• Supplement Dates FDA Received: 12/15/2017; 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 90