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

Model Number ICV1209

Device Problem Malposition of Device (2616)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer received the device back on dec.02, 2019.The device was received in good conditions and no abnormalities were observed.Based on the information provided the event was a malpositioning leading to paravalvular leak.The site performed an intra-operative explant and this caused a delay of 26 minutes.The event information indicates that the root cause was the malpositioning of the device and thus there is no device related malfunction or insufficiency.The manufacturer will not perform any further investigations and the root cause is determined to be user error - malpositioning.

Event Description

On (b)(6) 2019 a patient received a perceval pvs23 sutureless aortic heart valve as part of an avr.The patient was indwelled through a midline incision.Transesophageal echocardiography(tee) was performed after de-clamping, and it showed that the non-coronary cusp(ncc) of the device was placed slightly higher and there was perivalvular leakage.So the device was explanted and another perceval(serial# (b)(4)) was indwelled.The first x-clamp time was 26 minutes.The second x-clamp time was 35 minutes.Total cpb time was 146 minutes.The patient's condition was stable during this operation.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 9433898
• MDR Text Key: 169729572
• Report Number: 1718850-2019-01199
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220127
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2019,12/06/2019

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: 01/24/2022
• Device Model Number: ICV1209
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2019
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 65