MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA CONDUIT; CARBOSEAL VALSALVA SIZE 25 AORT

Model Number CP-025

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/10/2017

Event Type  Injury  

Event Description

Livanova was notified through a patient registration form that a cp-025 implanted in aortic position on (b)(6) 2014 has been explanted and a new cp-025 has been implanted.The reason of explant is still unknown.

Manufacturer Narrative

Based on the information provided in the event description, the event is attributable to patient factors and no device deficit is suspected.As such, no further investigation is required at this time.Device not returned.

Event Description

Manufacturer received additional information on 9-jan-2018: reason for explant of the device: "patient had a history of 3 previous root replacements.First for aortic aneurysm and then mechanical root for endocarditis, followed 6 weeks later by homograft.Patient had done well fro 2-3 years but 6 months ago had multiple infections and repeat imaging showed worsening mitral regurgitation and new pseudo aneurysm of the left main button and possible graft dehiscence.Patient had worsening chf from the mr and was hospitalized preoperatively for inotropic hemodynamic tailoring" note from operation report: "the previous homograft was exposed and completed excised.There appeared to be old healed vegetation on the left and non-homograft valve leaflets." patient outcome: patient was weaned from bypass - biventricular dysfunction - period of reperfusion on cpb and placement of iabp with tee guidance.Patient again weaned and was stable.Transported it icu in critical condition.Discharged (b)(6) 2016.

• Brand Name: CARBOSEAL VALSALVA CONDUIT
• Type of Device: CARBOSEAL VALSALVA SIZE 25 AORT
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7149730
• MDR Text Key: 95898012
• Report Number: 3005687633-2017-00139
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060/S02
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

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: No Information
• Device Expiration Date: 12/31/2016
• Device Model Number: CP-025
• Device Catalogue Number: CP-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/09/2018; 02/16/2018
• Supplement Dates FDA Received: 02/05/2018; 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2013
• 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): Hospitalization
• Patient Age: 38 YR