MAUDE Adverse Event Report: LIVANOVA CANDA CORP SOLO SMART STENTLESS HEART VALVE; TISSUE HEART VALVES

Model Number	ART21SMT
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a (b)(6) years old female patient underwent aortic valve replacement with solo smart size 21.During the same procedure, 4 cabgs were also performed.A week later, the patient¿s gradients were unusually high: 60mmhg (mean) and 90mmhg (peak).The surgeon reviewed the echo and determined that the valve was oversized as well as implanted too high on one side.On (b)(6) 2019, the valve was explanted and a magna ease 19 was implanted instead.The patient's mean gradient went down to 16mmhg immediately after the replacement of the device.The patient is doing well after the procedure.
Additional Manufacturer Narrative
The manufacturing and material records for the solo smart heart valve, model #icv1247, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1247) solo smart heart valve at the time of manufacture and release.The explanted prosthesis was returned to livanova and it was received on 04 feb 2019.The returned valve was received deeply damaged and in several portions, probably due to the explanting procedure.Further investigation is ongoing.
Additional Manufacturer Narrative
With the aim to confirm the correct size of the returned device, a dimensional analysis has been performed.As per verification, the correct matching is with the tool corresponding to the correct one for the solo smart size 21 (art21smt).Further analysis of the returned prosthesis was not possible due to the conditions in which the device was received.Based on the performed investigation and the information provided by the site, the event can be reasonably attributed to a mis-sizing of the device.
Event or Problem Description
On (b)(6) 2018, a 65 years old female patient underwent aortic valve replacement with solo smart size 21.During the same procedure, 4 cabgs were also performed.A week later, the patient¿s gradients were unusually high: 60mmhg (mean) and 90mmhg (peak).The surgeon reviewed the echo and determined that the valve was oversized as well as implanted too high on one side.On (b)(6) 2019, the valve was explanted and a magna ease 19 was implanted instead.The patient's mean gradient went down to 16mmhg immediately after the replacement of the device.The patient is doing well after the procedure.There was no perceived issue with the explanted solo smart.

• Brand Name: SOLO SMART STENTLESS HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8298772
• Report Number: 3004478276-2019-00118
• Device Sequence Number: 1991719
• Product Code: LWR
• UDI-Device Identifier: 00896208000467
• UDI-Public: (01)00896208000467(240)ICV1247(17)210217
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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: 02/17/2021
• Device Model Number: ART21SMT
• Device Catalogue Number: ICV1247
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/18/2019; 02/15/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/12/2019; 03/02/2019
• 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: 65 YR
• Patient Weight: 67