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

Model Number PVS25

Device Problems Difficult to Fold, Unfold or Collapse (1254); Kinked (1339)

Patient Problem No Information (3190)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

This event is being reported in a conservative manner, as the delay in procedure and patient outcome are unknown.The manufacturer was listed as livanova (b)(4) corp.In this report.However, as the serial number is presently unknown, the device may have been manufactured at sorin group (b)(4), livanova's sister company.The manufacturing information will be updated if the serial number is identified.Device available but not yet received.

Event Description

A perceval valve was prepared for implant, but the valve was hard to collapse, and the button on the holder accessory was hard to turn.Ultimately, the valve was implanted, but it did not deploy correctly.It was reported that there was an infolding on the left coronary side of the valve, even after ballooning.The valve was then removed, and the surgeon attempted to collapse the valve again, but it was not possible as the valve would not go onto the holder.A mosaic 23 was then implanted.

Manufacturer Narrative

Correction: two possible serial numbers ((b)(4) or (b)(4)) were originally reported.A third potential serial number, (b)(4), was identified, but was originally excluded due to evidence that the valve was manufactured at sorin (b)(4) (i.E.Serial number starts with "(b)(4)").However, this evidence was deemed insufficient to exclude the third serial number from consideration.Therefore, there are three possible serial numbers associated with this valve: (b)(4).A complete dhr review was performed for all three valves and the associated nitinol stent.The reviews confirmed that each device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the results of the investigation performed, the collapsing accessories can be excluded as the root cause of the event.The dehydrated state of the returned valve precluded an exhaustive investigation of the device.However, no manufacturing non-conformities were identified by visual inspection, and the dhr reviews performed confirmed the absence of manufacturing deficits.Furthermore, from the event description provided, the size 25 perceval valve was replaced with a size 23 mosaic valve.Based on the relative dimensions of these devices, it is reasonable to conclude that the root cause of this event was over-sizing.

Manufacturer Narrative

A paper was received with the devices reporting the serial number to be (b)(4).This serial number conflicted with the reported serial number, (b)(4).The manufacturer was unable to receive confirmation of the device serial number upon follow-up.Due to the dehydrated condition of the returned valve, visual inspection was limited to structural aspects, such as the manufacturing seams.No manufacturing non-conformities were observed.A simulation of the collapsing phases was performed with all the returned accessories, and the returned valve.Difficulties were encountered with positioning the valve; however, it was possible to cover the inflow portion of the valve with the inflow cap.The metallic outflow crown did not collapse properly due to irregular, non-circular geometry.The valve could therefore not be completely collapsed.The collapsing simulation was repeated with the returned accessories and a demonstration valve.No anomalies were detected during this procedure, thereby excluding the accessories as the possible root cause of the event.Based on the results of the investigation performed, the collapsing accessories can be excluded as the root cause of the event.The dehydrated state of the returned valve precluded complete investigation of the device.However, no manufacturing non-conformities were identified by visual inspection.

Manufacturer Narrative

Device was received by manufacturer on january 30, 2018.The returned valve was received still partially collapsed on the cap of the dual holder and the valve was in dry conditions without any kind of storage solution.Stent was found deformed on the outflow ring.

Event Description

On (b)(6) 2018, manufacturer received confirmation that the native valve was not bicuspid and no concomitant procedures were performed.No other information was available.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• 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: 7202504
• MDR Text Key: 97635560
• Report Number: 3004478276-2018-00118
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• 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