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

Model Number PVS27

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problems Aortic Insufficiency (1715); Death (1802); Sepsis (2067)

Event Date 08/23/2016

Event Type  Death  

Manufacturer Narrative

Not explanted.

Event Description

On (b)(6) 2016, a percival valve size xl was implanted in a patient with an (b)(6) active valve endocarditis (limited to the leaflets without annular involvement).During the same surgery a double cabg was performed.The intra-operative tee did not show presence of valvular leaks.Patient experienced difficulty coming off bypass and an intra-aortic balloon pump was implanted.Two hours after the surgery, tte was performed and a perivalvular leak was detected around the anterior aspect of the percival.The aortic balloon pump was removed and an impala lvad was implanted.On (b)(6) 2016 patient was taken to the catheterization lab, a 25mm balloon catheter was inflated at the subangular level of the percival's inflow ring.Simultaneously a catheter-introduced grasper was attached to the valve's outflow ring.With this maneuver the percival's tilt was corrected and the tee showed good valvular gradient and the paravalvular leak was completely resolved.The patient later succumbed to sepsis.The surgeon feels the patient death was not valve-related.

Manufacturer Narrative

The complete manufacturing and material records for the perceval heart valve, model icv1211, s/n (b)(4), were pulled and reviewed by quality control at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a perceval heart valve at the time of manufacture and release.Based on the medical judgement provided, the patient died as a result of sepsis and was not related to the valve.No further investigation is required.

• 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
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 5975469
• MDR Text Key: 55562628
• Report Number: 3004478276-2016-00109
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)190314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 61