MAUDE Adverse Event Report: LIVANOVA CANADA CORP. SOLO SMART SUPRA-ANNULAR HEART VALVE; TISSUE HEART VALVE

Model Number ART27SMT

Device Problem Incomplete Coaptation (2507)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The information was reported to livanova by the patient.The solo smart valve was implanted on (b)(6) 2015 at (b)(6) hospital.

Event Description

The manufacturer was notified on 01-nov-2016 by the patient of the following: a solo smart valve was implanted on (b)(6) 2015.One of the leaflets was not closing.The patient is scheduled for valve-in-valve reoperation.

Manufacturer Narrative

The complete manufacturing and material records for the solo smart heart valve, model icv1265, s/n (b)(4), were retrieved 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 (model icv1265) solo smart heart valve at the time of manufacture and release.No further information has been received by the manufacturer to date of the proposed tavi procedure, based on the limited information provided, it is not clear what the complete reason for proposed tavi was therefore no conclusion can be drawn.No further investigation is possible at this time.

• Brand Name: SOLO SMART SUPRA-ANNULAR 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, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 6133861
• MDR Text Key: 61083435
• Report Number: 3004478276-2016-00157
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000498
• UDI-Public: (01)00896208000498(240)ICV1265(17)180226
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

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: 02/26/2018
• Device Model Number: ART27SMT
• Device Catalogue Number: ICV1265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: 04/05/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2018
• 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: 79 YR