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

Model Number	ART23SMT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported to the manufacturer through the (b)(6) clinical registry.The site reported as unknown device relation.The manufacturer requested the internal clinical review of the event which determined as unknown device relation.As reported in the scientific literature "stroke is a devastating complication that may occur early or late after operation in patients with prosthetic heart valves and result from embolism, intracranial hemorrhage, or both although intracranial hemorrhage is a relatively rare event except in elderly anticoagulated patients, an embolic stroke may occur in virtually any patient and with any type of valve prosthesis.Risk factors for stroke in the general population include advanced age, atrial fibrillation, coronary artery disease, congestive heart failure, mitral annular calcification, hypertension, diabetes, and smoking.In patients with prosthetic heart valves, these and other patient-related characteristics could interplay with the design of the prosthesis, the site of implantation, and the adequateness of anticoagulation." ruel, marc, et al."late incidence and determinants of stroke after aortic and mitral valve replacement." the annals of thoracic surgery 78.1 (2004): 77-83.Device not explanted.
Event or Problem Description
This event was reported to the manufacturer through the (b)(6) clinical registry: a solo smart size 23 was implanted on (b)(6) 2016 via mini- sternotomy.The valve was implanted supra-annular.On (b)(6) 2017, the patient exhibited stroke and it was reported by the site as unknown for device relation.

• Brand Name: SOLO SMART STENTLESS HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7100507
• Report Number: 3004478276-2017-00212
• Device Sequence Number: 19170436
• 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
• Report Date (Section B): 12/08/2017

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: Physician
• Device Expiration Date: 09/12/2019
• Device Model Number: ART23SMT
• Device Catalogue Number: ICV1248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 12/08/2017
• 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: Other
• Patient Weight: 53