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

Model Number PVS21

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

Event Description

The manufacturer was informed of this event through the device tracking department.Based on the information reported on the patient implant form, a perceval valve pvs21 was implanted and explanted on (b)(6) 2019.Another perceval valve pvs21 was finally implanted on the same day.No further information is presently available.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model# icv1208, serial# (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# icv1208 (pvs21) perceval heart valve at the time of manufacture and release.The manufacturer made several attempts to follow-up for further information, however, at this time no further information has been received.If further information is received the manufacturer will reassess the investigation.At this time because no further information is available and the device is not available for analysis the root cause cannot be established as no event modes have been identified.

• 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: 10509823
• MDR Text Key: 206310609
• Report Number: 3004478276-2020-00183
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)220104
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2022
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR