MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW VALSALVA CONDUIT; TISSUE HEART VALVE

Model Number MVC030

Device Problem Insufficient Information (3190)

Patient Problems Thrombosis (2100); Blood Loss (2597)

Event Date 02/23/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer that there was thrombosis with in the conduit/valve post operatively.The patient was having an aortic root replacement.The patient returned from initial operation and had some problems with bleeding.The patient settled with products.A few hours later the patient had a sudden drop in blood pressure not responsive to initial attempts to restore pressure and then proceeded to have a pea arrest.Chest was opened and placed on bypass.Due to his ecg changes the surgeon decided to open the ascending aorta and inspect the coronary buttons.He found a large clot in the left main stem orifice which he evacuated.The aorta was closed and an intra-aortic balloon pump was inserted and inotropic support was recommenced.He steadily improved and he was anticoagulated to prevent further clot formation.No devices were explanted.

Manufacturer Narrative

The manufacturing and material records for the vascular component of the mitroflow valvsalva conduit were retrieved by the supplier, vaskutek, and provided to (b)(4).The records were confirmed per the supplier¿s verification.A complete manufacturing and material records review for the mitroflow valsalva conduit was performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the performed analyses, no manufacturing deficits were identified.As the device was not explanted, no further investigation can be performed at this time, and the root cause of the event is unknown.Per the instructions for use of the mitroflow valsalva conduit, adverse events potentially associated with the use of vascular grafts include "occlusion (including thrombosis and anastomotic intimal hyperplasia)".As such, this is a known, inherent risk of the procedure.Date received by manufacturer.Device evaluated by manufacturer.Device not explanted.

• Brand Name: MITROFLOW VALSALVA CONDUIT
• 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): SORIN GROUP ITALIA; via crescentino sn; saluggia
• Manufacturer Contact: francesca crovato ; 5005 fraser north way; burnaby, bc
• MDR Report Key: 6492346
• MDR Text Key: 72779029
• Report Number: 3004478276-2017-00059
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P060038
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: MVC030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 32 YR