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

Model Number	ART27SMT
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	05/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown disposition.
Event or Problem Description
On (b)(6) 2018 a patient received a solo smart size 27 aortic heart valve implant.The manufacturer was notified via the patient tracking system that the device was explanted on (b)(6) 2020 and replaced with a perceval pvs23 sutureless aortic heart valve.Additional information received identifying the following.The procedure in 2018 was performed without issue.The patient required the re-do procedure in 2020 due to severe as.
Event or Problem Description
On (b)(6) 2018 a patient received a solo smart size 27 aortic heart valve implant.The manufacturer was notified via the patient tracking system that the device was explanted on (b)(6) 2020 and replaced with a perceval pvs23 sutureless aortic heart valve.Additional information received identifying the following.The procedure in 2018 was performed without issue.The patient required the re-do procedure in 2020 due to severe as.Regarding the sizes of the two valves, it was reported that it is typical to use a 23mm perceval valve in a previous 27mm solo valve.No further information was provided.
Additional Manufacturer Narrative
The manufacturing and material records for the solo smart heart valve, model #icv1265, 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 #icv1265) solo smart heart valve at the time of manufacture and release.Since the device was not returned for analysis, no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive conclusion on the reported event.However, from the document review performed, no manufacturing deficits were identified.The root cause of the reported event cannot be established at this time.

• 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: 10878548
• Report Number: 3004478276-2020-00235
• Device Sequence Number: 19556973
• Product Code: LWR
• UDI-Device Identifier: 00896208000498
• UDI-Public: (01)00896208000498(240)ICV1265(17)200413
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 04/13/2020
• Device Model Number: ART27SMT
• Device Catalogue Number: ICV1265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/18/2020
• 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