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

Model Number	ART25SMT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported in a conservative manner as limited information is known to date, included unknown delay in the procedure due to failure to implant.The manufacturer is in contact with the hospital to gain further information on this event.Not yet determined if device available.
Event or Problem Description
On (b)(4) 2017 the manufacturer was notified through patient tracking of the following event: on (b)(6) 2017 an intra-operative failure to implant of solo smart size 25 occurred.A crown prt pericardial heart valve size 25 was then implanted.The delay in the procedure is unknown at this time.
Additional Manufacturer Narrative
The manufacturer attempted several times to retrieve further information without success.
Additional Manufacturer Narrative
The complete manufacturing and material records for the solo smart heart valve, model #icv1264 , s/n # (b)(4) were pulled and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1264) solo smart heart valve at the time of manufacture and release.As the manufacturer was unable to obtain additional information about this event, the root cause remains unknown.However, based on the document review performed no manufacturing deficits were identified, and there is no information to suggest the event is related to the device.

• 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: 7007014
• Report Number: 3004478276-2017-00182
• Device Sequence Number: 11162829
• Product Code: LWR
• UDI-Device Identifier: 00896208000481
• UDI-Public: (01)00896208000481(240)ICV1264(17)200326
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 03/26/2020
• Device Model Number: ART25SMT
• Device Catalogue Number: ICV1264
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 02/06/2018; 02/22/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 02/06/2018; 03/01/2018
• 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: Required Intervention
• Patient Age: 70 YR