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

Model Number PVS21

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Insufficiency (1715)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned to the manufacturer and it was received on 14 dec 2018.The returned prosthesis was received in good conditions with traces of blood visible both on the inflow and on the outflow side.Further investigation is ongoing.

Event Description

On (b)(6) 2018, a perceval pvs21 implant attempt occurred.However, after the implant, a small central leak was observed.After de-clamping and weaning from bypass, the device showed a big central leak.The patient was consequently put on bypass again, the device was explanted and replaced with a perimount 21mm.The extra cross-clamp time and bypass time added to the procedure were, respectively, 56min and 85min.According to the surgeon's judgment, no mis-sizing occurred.

Event Description

On (b)(6) 2018, a perceval pvs21 implant attempt occurred in a patient with aortic insufficiency.The procedure was performed in full sternotomy.However, after the implant, a small central leak was observed.After de-clamping and weaning from bypass, the device showed a big central leak.The patient was consequently put on bypass again, the device was explanted and replaced with a perimount 21mm.The extra cross-clamp time and bypass time added to the procedure were, respectively, 56min and 85min.The patient remained stable throughout the procedure and had a good outcome after surgery.According to the surgeon's judgment, no mis-sizing occurred and there was no perceived issue with the perceval valve.A concomitant procedure was performed on that same day - cabg with partial camping for the venous graft anastomosis.It was not reported whether it occurred before or after the perceval implant.

Manufacturer Narrative

The results of the visual inspection showed sign of damage of the pericardium in correspondence of the second pillar, not associable to pre-existing defects but, rather, they can be reasonably attributable to the manipulation of the device during the implanting/explanting procedure.In order to allow an exhaustive evaluation of the functional behavior, the valve underwent hydrodynamic testing in simulated physiological conditions.The results showed that the device meets the iso 5840 minimum requirements and that the reported issue was not reproduced.Furthermore, the steady flow test inspection was reviewed which demonstrate the acceptable opened and closed leaflet performance of the perceval pvs21 sn# (b)(6).No anomalies are observed during the open/close cycle.The valve, therefore, meets the acceptance criteria of the steady flow test inspection defined in the principal device function test at the time of release.Finally, the manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Based on the investigation performed, it was not possible to reproduce the claimed central leak and it is possible to determine a root cause of the event at this time.

• 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
• MDR Report Key: 8207215
• MDR Text Key: 131792102
• Report Number: 3004478276-2018-00374
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)191105
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2019
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 61