MAUDE Adverse Event Report: LIVANOVA CANADA CORP. SOLO SMART STENTLESS HEART VALVE; TISSUE HEART VALVE

Model Number	ART21SMT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/02/2016
Additional Manufacturer Narrative
Unknown if the device will be returned.
Event or Problem Description
The manufacturer was notified on 29-sept-2016 of the following information received through the patient tracking form: a female patient had a solo smart valve explanted on (b)(6) 2016.
Event or Problem Description
E-mail received from pt (b)(6) on 29 sep 2016: received a patient registration form (prf) for patient (c.M.Female, dob (b)(6)) who had a art21smt sn# (b)(4) explanted on (b)(\6) 2016 at (b)(6).Hospital¿s address is (b)(6).Nov 3, 2016 update from usa sales: there was no issue with the valve.Once chest was open and sized the doctor decided solo was not valve for that patient after they already opened it.This was all the information that was able to be obtained.

• Brand Name: SOLO SMART STENTLESS HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6065122
• Report Number: 3004478276-2016-00141
• Device Sequence Number: 441126
• Product Code: DYE
• UDI-Device Identifier: 00896208000467
• UDI-Public: (01)00896208000467(240)ICV1247(17)191102
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: ART21SMT
• Device Catalogue Number: ICV1247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2016
• Supplement Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR