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

Model Number	ART21SMT
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Codes	Death (1802); No Information (3190)
Date of Event	04/20/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
This event was received from the sure avr clinical registry.The site reported the event as inappropriate sizing/positioning.Internal clinical review has determined this event may be attributed to the device.Not available for return.
Event or Problem Description
This event was reported to the manufacturer through the (b)(6) registry: a solo smart size 21 was implanted on (b)(6) 2016 via median-sternotomy.The valve was implanted supra-annular with non-everting suture technique.On (b)(6) 2017, the patient exhibited non structural dysfunction which was reported by the site as due to inappropriate sizing and positioning.
Additional Manufacturer Narrative
The complete manufacturing and material records for the solo valve were pulled and reviewed by quality engineering at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a solo valve at the time of manufacture and release.Since the device was not explanted , the structural valve deterioration cannot be confirmed.Also since no autopsy was performed root cause of patient death was not identified.
Event or Problem Description
The manufacturer was notified that the patient passed away.It was also clarified that signs of early structural valve deterioration (svd) has been identified previous patient death.The cause of death remains unknown since no autopsy was performed.

• 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: 7098153
• Report Number: 3004478276-2017-00207
• Device Sequence Number: 1183092
• Product Code: LWR
• UDI-Device Identifier: 00896208000467
• UDI-Public: (01)00896208000467(240)ICV1247(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
• Report Date (Section B): 01/26/2018

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: Physician
• Device Expiration Date: 09/12/2019
• Device Model Number: ART21SMT
• Device Catalogue Number: ICV1247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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: Death; Required Intervention
• Patient Weight: 91