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

Model Number	ART23SMT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.
Event or Problem Description
The manufacturer was notified of the following event via the sure-avr patient registry: a solo smart size 23 was implanted on (b)(6) 2016.At the time of operation, a mean gradient of 11 mmhg and paravalvular leak 1+ were reported.The patient experienced thrombocytopenia on (b)(6) 2016.The valve was functioning well at follow up in (b)(6) 2017, with a mean gradient of 12 mmhg and no central or paravalvular leak.The total cross-clamp time was 59 minutes, and the total pump time was 72 minutes.The event was reported by the site as "valve related".
Additional Manufacturer Narrative
The manufacturing and material records for the solo smart heart valve, model #icv1248 , s/n # (b)(4), 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 #icv1248) solo smart heart valve at the time of manufacture and release.Based on the document review performed, no manufacturing deficiencies were identified.Given that the patient's thrombocytopenia resolved without transfusion, and the device remained implanted and was functioning well one year post-operatively, the event is unlikely to be related to the functionality of the device.Furthermore, thrombocytopenia is a known complication associated with cardiopulmonary bypass.It is therefore possible that the event is related to the procedure and not to the device.However, as no device investigation can be performed, the root cause of the event cannot be determined.
Event or Problem Description
The manufacturer was notified of the following event via the sure-avr patient registry: a solo smart size 23 was implanted on (b)(6) 2016.At the time of operation, a mean gradient of 11 mmhg and paravalvular leak 1+ were reported.The patient experienced thrombocytopenia on (b)(6) 2016.The valve was functioning well at follow up in (b)(6) 2017, with a mean gradient of 12 mmhg and no central or paravalvular leak.The total cross-clamp time was 59 minutes and the total pump time was 72 minutes.The physician reported that the thrombocytopenia was believed to be attributable to the solo valve.Assay for heparin-induced thrombocytopenia was negative.The patient was not transfused.

• 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 V5J5M 1; CA V5J5M1
• MDR Report Key: 7904091
• Report Number: 3004478276-2018-00295
• Device Sequence Number: 165228
• Product Code: LWR
• UDI-Device Identifier: 00896208000474
• UDI-Public: (01)00896208000474(240)ICV1248(17)190912
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2019
• Device Model Number: ART23SMT
• Device Catalogue Number: ICV1248
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 11/01/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/30/2018; 11/01/2018
• 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: Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 103