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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

A series of preliminary analysis have been conducted: on 05 oct 2018, the gross examination of the returned device was completed.The returned prosthesis valve has been received in general good conditions, even if the storage liquid did not cover the entire valve.On 10 oct 2018, a complete manufacturing and material records review for the nitinol stent component has been performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.On 23 oct 2018, the review of the steady flow test performed on the device at the time of release was completed.The review of the steady flow test inspection performed on the device at the time of release confirmed that the valve demonstrate the acceptable opened and closed leaflet performance of the perceval pvs25 sn# (b)(4).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in (b)(4), the principal device function test at the time of release.Further device testing is ongoing.

Event Description

On (b)(6) 2018, a perceval pvs21 was implanted and explanted intra-operatively because perivalvular leak was observed after implant of the valve and de-clamp of the aorta.It was observed that the valve had moved up about 1 cm, for which reason the perceval was explanted and a perimount 19mm was implanted instead.The annulus was properly debrided before implanting perceval and no manipulation of the heart occurred after the device implant.Moreover, it is reported that the small hypertrophic lvot may have caused the device pop-up.The patient is in good conditions, despite the extra x-clamp time (31 minutes) added to the procedure.

Event Description

On (b)(6) 2018, a perceval pvs21 was implanted and explanted intra-operatively because a perivalvular leak was observed after implant of the valve and de-clamp of the aorta.It was observed that the valve had moved up about 1 cm, for which reason the perceval was explanted and a perimount 19mm was implanted instead.The annulus was properly debrided before implanting perceval and no manipulation of the heart occurred after the device implant.Moreover, it is reported that the small hypertrophic lvot may have caused the device pop-up.The patient is in good conditions, despite the extra x-clamp time (31 minutes) added to the procedure.

Manufacturer Narrative

The device returned to the manufacturer's site on (b)(6) 2018 for analysis.The gross examination performed on the returned prosthesis confirmed that the device was received in good conditions, even if the storage liquid did not cover the entire valve.A visual inspection was also conducted on the device.The results showed the absence of pre-existing defects.Furthermore, a dimensional verification and a deployment simulation were performed.The dimensional analysis was performed using a dedicated go ¿ no go gauge (vr 251) to verify that the device still meets the dimensional specifications: both the valve inflow side and sinusoidal structures, pass through the holes indicated as 'pass' and do not pass through the 'not pass' holes, confirming the correct dimensions of the returned device according to the specifications.In order to replicate the reported event, and evaluate the concomitant functional behavior of the device, a simulation of collapsing, deployment and ballooning phases was performed.A static leak test was also conducted.No problems were encountered during the simulation of the device deployment; the valve remained fixed within the annulus without observing significant anomalies.No perivalvular leaks were observed after adding water to the aortic root from the outflow side.The water level remained stable under the leaflets free edge.Finally, a review of the manufacturing and quality records was performed.The review of the steady flow test inspection performed on the device at the time of release confirmed that the valve demonstrates the acceptable opened and closed leaflet performance of the perceval pvs25, sn# (b)(4).No anomalies are observed during the open/close cycle.The valve, therefore, meets the acceptance criteria of the steady flow test inspection defined in 850-08ip203 rev p, the principal device function test at the time of release.The results of the complete manufacturing and material records review confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the above-detailed results of the investigation, the reported event cannot be traced to any factor intrinsic to the device.The device which was ultimately implanted to the patient was a perimount 19mm, whose inner diameter is 18mm.The perceval pvs21 can fit annulus diameters ranging from 19mm to 21mm.Considering this dimensional comparison, and the claimed patient¿s small hypertrophic lvot, the event is believed to be related to a possible mis-sizing and/or mal-positioning of the device.The manufacturer¿s in-service guide lists the lvot hypertrophy as a factor that may prevent optimal expansion of the inflow portion of the stent.In such cases, a myectomy is recommended prior to perceval implant.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• MDR Report Key: 8003027
• MDR Text Key: 124964905
• Report Number: 3004478276-2018-00313
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)200707
• 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
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2020
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention