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

Model Number PVS23

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abscess (1690); Endocarditis (1834)

Event Date 09/02/2020

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) corp.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.Since the device was discarded, no further investigation is possible at this time.Based on the available information, the root cause of the reported event cannot be definitively stated.However, based on the document review performed, no manufacturing nor quality deficits were identified.Endocarditis is listed as a possible adverse event in the perceval instructions for use (ifu).The event is, therefore, a known inherent risk of the device.The manufacturer has requested additional information on this event.Should any relevant additional information be received, a follow up will be submitted within the required timeline.

Event Description

On (b)(6) 2020, a patient received a perceval pvs23 in aortic position.The manufacturer was informed that the device was explanted due to infective endocarditis on (b)(6) 2020.It was reported that there were many abscesses, with extended from around the mitral valve to the aortic valve.An abscess removal and lavage of the tricuspid valve, mitral and aortic valve abscess removal were performed, as well as a repair using pericardial patch.At sizing, s size white sizer was not able to pass through due to the repair using a patch, so mosaic 21mm (medtronic) was implanted.

Manufacturer Narrative

Based on the late onset of the endocarditis (>60 days after device implant) and considering the medical judgment received confirming that this case is not a complaint, there is not enough evidence to reasonably suspect a device malfunction which could have caused or contributed to the reported event.Furthermore, based on the document review performed, no manufacturing nor quality deficits were identified.As such, based on the available information, the root cause of the reported event cannot be traced to the device.It should be noted that endocarditis is listed as a possible adverse event in the perceval instructions for use (ifu).The event is, therefore, a known inherent risk of the device.

Event Description

On (b)(6) 2020, a patient received a perceval pvs23 in aortic position.The manufacturer was informed that the device was explanted due to infective endocarditis on (b)(6) 2020.It was reported that there were many abscesses, with extended from around the mitral valve to the aortic valve.An abscess removal and lavage of the tricuspid valve, mitral and aortic valve abscess removal were performed, as well as a repair using pericardial patch.At sizing, s size white sizer was not able to pass through due to the repair using a patch, so mosaic 21mm (medtronic) was implanted.Per the medical judgment received, this case is not considered as a complaint and no further information will be provided.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10600692
• MDR Text Key: 209775982
• Report Number: 1718850-2020-01152
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230220
• 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: 09/03/2020,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR