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

Model Number PVS23

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problems Thrombosis (2100); Thrombus (2101)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer is the process to obtain the return of the device.Since no serial number was provided from the customer, at this time the manufacturer facility is unknown.The perceval valves for the european market are manufactured in two facilities: livanova sorin group (b)(4).Livanova canada corp.(b)(4).

Event Description

The manufacturer was notified on 11 jan 2016 that a female patient, first implanted with an enable in (b)(6) 2015.Intraoperatively enable did not stay in position, as the aortic annulus was not truly symmetric.The surgeon decided to switch to a perceval, which could be positioned easily and showed good gradients.Five month after implant, the patient came back with severe symptoms.The medical check showed thrombus on all tree leaflets and a re-operation was done to change to a stented valve.After a follow-up with the surgeon, the manufacturer received the following information: female patient, (b)(6), severe aortic stenosis (ppg 72 mmhg, mpg 47 mmhg, ava 0.5 cm2) minimally invasive right anterior thoracotomy savr with perceval postoperative echocardiography afer perceval: ppg of 26 mmhg and no perivalvular leak (pvl).A permanent pacemaker was implanted in the postoperative course for sinus bradycardia.Anticoagulation protocol after biological avr was followed (including low molecular weight heparin along with 100mg of acetylsalicylic acid once daily lifelong and 75 mg of clopidogrel once daily for 6 weeks).After full mobilization low molecular weight heparin was discontinued.Xx months (not exactly known till know - waiting for the medical report of that center) after the savr she presented to her local health practitioner with chronic back pain and received a high dose cortisone therapy.Shortly thereafter she developed progressive shortness of breath on exercise.Laboratory tests: no signs of inflammation.Echo: thrombus formation within the right and non coronary sinus leading to leaflet immobility and elevated transvalvular gradient.Contrast enhanced computer tomography validated the thrombus formation redo: the prosthesis was partially incorporated into the aortic root but could be removed without collateral damage.Valve substitute: edwards perimount size 21 with postoperative echocardiography: ppg 15 mmhg, no leak histological examination revealed thrombotic material free from inflammation.No bacterial contamination could be found.

Manufacturer Narrative

Device not returned.

• 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
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1 ; 4125696
• MDR Report Key: 5429595
• MDR Text Key: 37966514
• Report Number: 3004478276-2016-00003
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/30/2018
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR