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

Model Number PVS25

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716)

Event Date 08/05/2020

Event Type  Injury  

Event Description

Patient is a (b)(6) year old who was identified with critical aortic stenosis.Procedure was an isolated savr, with a minimally invasive approach via right thoracotomy.Operation was performed on (b)(6) 2020.The patient had a heavily calcified bicuspid aortic valve with significant extension of the calcium in to the anterior leaflet of the mitral valve.This was debrided and the valve was sized for a perceval large.The valve was implanted as per standard protocol and after cross clamp removal, we could see on tee that the valve had aortic insufficiency around the non coronary commissure with significant ai.Patient was reopened.Some of the annulus was visualized under the valve suggesting it had not seated fully.The valve was removed, recollapsed and re deployed.Site was satisfied with second deployment.Off bypass, the tee demonstrated excellent function of the perceval with no ai or paravalvular leak.The patient did well and went home on pod #7.Echo in (b)(6) 2020 and a clinical follow up with cardiology in july identified patient becoming more out of breath and in nyha class 2.Echo showed moderate to severe paravalvular ai with the valve seated about 2.5 cm into the lv.On august 7th the valve was explanted.It was identified the valve had dropped approximately 2.5cm into the lv.Once the perceval was removed the surgeons used the perceval sizers to check the annulus and it sized for a large.The surgeons elected to implant a sutured valve in the patient and implanted a medtronic mosaic size 25mm.Prior to implanting the sutured valve the surgeons removed a 1cm x 2cm piece of thick tissue from the annulus.The intraoperative tee showed no issues with the sutured valve.

Manufacturer Narrative

The device was returned to the manufacturer for analysis.A gross and visual analysis was performed.A black suture thread is knotted to the green eyelet between post 1 and post 2.In the inflow a large portion of the inflow was covered by pannus, partially protruding inside the lumen.The outflow side of the skirt was almost completely covered by pannus, except the third leaflet.The pannus was protruding from the internal surface toward the outer surface of the leaflets.A dark area (likely blood residue or thrombus) is visible on the outflow surface of leaflet 3.The lateral portion of the skirt is partially covered by a thin pannus layer.All the three posts are covered by pannus.The nitinol stent was partially covered by pannus with the majority of the pannus focused to the outflow crown between post 1 to post 2 and on the sinusoidal struts in front of leaflet 1.Analysis of the protruding pannus shape resulted in similarities to the geometry of the valsalva sinus where the sinusoidal strut would be seated.There is no information identifying the final position of the features of the migrated valve with respect to the anatomical geometry, thus associations between the valve orientation prior to explant and the investigation findings cannot be confirmed.It is not possible to exclude that the pannus overgrowth described above is associated with a tilt and shift of the valve after the device migrated.The final positioning of the valve may have resulted in different clearance and contact areas with the aorta wall / valsalva¿s sinus which may have contributed to the detected pannus overgrowth.Consequently this growth may have contributed to a progressive stiffening of the leaflets reducing their mobility.In conclusion taking into consideration that the valve migrated, even if the immediate postoperative tee did not show any problems of perivalvular leak and / or aortic insufficiency, it is not possible to exclude that the re-collapsing and repositioning procedure may have caused an alteration of the device, not immediately detectable, but causing its migration at a later time.Due to the altered state of the returned prosthesis, it is not possible to give a final judgment on the device, as no further investigations are possible.Regarding the recollapsing of the valve the perceval instructions for use states: "warning: a removed perceval prosthesis must not be re- implanted, because its integrity is no longer ensured." given this information the re-implantation of the valve is an off ifu procedure as the valve is not intended to be recollapsed.In this case there was no immediate impact as a result of the off ifu action, however, its relationship to the device migration cannot be established.The root cause is thus cause traced to user : cause traced to intentional off-label, unapproved, or contraindicated use: contraindicated use.

• 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
• MDR Report Key: 10492031
• MDR Text Key: 205671968
• Report Number: 1718850-2020-01126
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/05/2020,09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2020
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR