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 Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

Event Description

The manufacturer was informed on this event through the device tracking department.Based on the information reported in the patient implant form, a perceval pvs23 was implanted and explanted on (b)(6) 2020.No further information is presently available.No allegation of a device malfunction nor of serious injury was received from the site regarding this event.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, 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 #icv1209) perceval heart valve at the time of manufacture and release.The manufacturer attempted to retrieve additional information, but no further details on the event has been received up to date.Based on the available information, a definitive root cause cannot be established at this time.However, per the document review performed, no manufacturing deficits were identified.Should further information be received in the future, the manufacturer will provide an update to this reporting activity.

• 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: 10568173
• MDR Text Key: 207995315
• Report Number: 3004478276-2020-00194
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230115
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR