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

Model Number PVS23

Device Problems Material Too Rigid or Stiff (1544); Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834); Unspecified Infection (1930); Fungal Infection (2419); Heart Block (4444)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Further investigation will be performed upon receipt of the device.

Event Description

On (b)(6) 2020, a patient received a perceval pvs23 in aortic position.No problems were reportedly identified at the follow up visit on 25 nov 2020.In early december, the patient was admitted to the hospital because of av-block and aortic stenosis which seems to be caused by infection.The perceval valve leaflets had almost no motion.The device was explanted on (b)(6) 2020 due to candida prosthetic valve infection.The explanted perceval pvs23 valve was replaced with an inspiris valve 23mm.An antifungal drug was administered for a week.At the time of explant of the perceval valve, no abnormality was found on the annulus.

Manufacturer Narrative

Fields updated: b4, f6, f7, f10.Examination of the returned prosthesis revealed a stenotic valve due to thrombus depositions on both prosthetic sides.The tops two posts were covered by white thrombus that grew on the free edges of leaflets contributes to stenosis.Reddish areas due to coagulated blood entrapment were present on almost all surfaces.Large white thrombus depositions were detected on all inflow surfaces.X-rays of the subject valve showed no calcification.Histological analyses were performed on samples taken from two leaflets.The hematoxylin and eosin stains showed that the collagen bundles were disrupted and homogenated.Inflammatory cells were present on the leaflet samples and inside the thrombus depositions.Thrombus depositions were visible on both surfaces the leaflets.Fungal hyphae, with septate morphology, were visible inside the leaflets and inside the thick thrombus depositions that are present on both surfaces.Some degenerated cells were visible under the mesothelial surface of one leaflet.Bacteria were not detected with the gram stain.In the leaflets, pas stain confirms fungal hyphae, with septate morphology, inside the pericardium and inside the thick thrombus depositions.The perceval s valve model #icv1209 , s/n # (b)(6) was explanted after 4 months due to a reported candida prosthetic valve infection.Gross examination revealed a stenotic prosthesis due to large thrombus depositions on both prosthetic sides.Histological analysis revealed inflammatory cells and fungal hyphae, with septate morphology, spread inside the pericardium of samples and inside the thick thrombus depositions.The presence of thrombus depositions, inflammatory cells and fungi indicated the endocarditis due to fungal infection, confirming the reported event.If candida was present on our tissue valve before sterilization, it would be killed very easily by our liquid chemical sterilant.The sterilant contains a mixture of glutaraldehyde and alcohol, both of which are highly effective against [insert organism].We have validated this liquid chemical sterilization process with spore forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.Following routine sterilization, the valves are aseptically packaged in a solution that inhibits growth of microorganisms with steam sterilized closures and jars.The packaging process occurs in a vaporous hydrogen peroxide (vhp) decontaminated isolator; therefore there is no risk of valve contamination post-sterilization.Each closure/jar containing the valve is integrity tested after packaging, thus ensuring a sealed barrier for the product to remain sterile during transport up until the closure/jar is opened.Furthermore, the device functionality was checked approximately 3 weeks before the event, and no problems were identified.Given that the valve was functional prior to the event, and that the onset of endocarditis was delayed (approximately 4 months post-implant), the event can reasonably be concluded as not device-related, and can be attributed to the patient's specific clinical condition.It should be noted that endocarditis is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.

• 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: 11159661
• MDR Text Key: 227073635
• Report Number: 1718850-2021-01001
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220426
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2020,05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2021
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2020
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 60