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

Model Number PVS23

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

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 canada 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.The manufacturer is following up with the site to retrieve additional information on the device disposition, details on the event and patient impact.No further information has been received to date.Based on the limited information available, it is not possible to draw a definitive conclusion on the reported event and cause of explant.However, per the document review performed, no manufacturing deficiencies were identified.Should further information be received, the manufacturer will provide an update to this reporting activity.Presently, the root cause of the reported event cannot be established.

Event Description

The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, a perceval pvs23 was explanted.No further information on the implant time, reason for the explant and patient impact is presently available.No indication of a device malfunction nor serious injury was received from the site regarding this event.

Manufacturer Narrative

Updated sections b4, f6, f7, f10, specifically to correct the coding (health effect - impact code).

• 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: 11240496
• MDR Text Key: 231716545
• Report Number: 1718850-2021-01010
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230530
• 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: 12/28/2020,03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• 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: 03/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2020
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR