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

Model Number	ART23SMT
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Death (1802); Tachycardia (2095)
Date of Event	12/07/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
The solo smart 23 was implanted without success.Intra-operative tee showed the leaflets did not open correctly.The solo smart 23 was explanted and a solo smart 21 was implanted.The right ventricle regained its own rhythm, however the left ventricle was completely non-functional.The patient remained on bypass and was eventually switched to ecmo and transferred to baylor for emergent l-vad, however expired shortly after arriving.
Additional Manufacturer Narrative
The partial manufacturing and material records for the solo smart heart valve, model #icv1248 , s/n # (b)(4) were pulled and reviewed by quality engineering at livanova (b)(4).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 results of the document review performed, no manufacturing deficits were identified.From the event description, mis-sizing may have been a contributing factor in this event, but this cannot be confirmed.The reported tachycardia may have been a procedure-related complication; however, this also cannot be confirmed, and as the device was not available for return, the root cause of the event ultimately cannot be determined.Device not available for return.
Event or Problem Description
A solo smart 23 was implanted without success.Upon releasing the cross-clamp, the patient became tachycardic, requiring multiple defibrillations, with the right ventricle not ejecting.Intra-operative tee showed the leaflets did not open correctly.The solo smart 23 was explanted and a solo smart 21 was implanted.The right ventricle regained its own rhythm, however the left ventricle was completely non-functional.The patient remained on bypass and was eventually switched to ecmo and transferred to baylor for emergent l-vad, however expired shortly after arriving.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7236142
• Report Number: 3004478276-2018-00121
• Device Sequence Number: 13487796
• Product Code: LWR
• UDI-Device Identifier: 00896208000474
• UDI-Public: (01)00896208000474(240)ICV1248(17)200124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/01/2018

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: Physician
• Device Expiration Date: 01/20/2020
• Device Model Number: ART23SMT
• Device Catalogue Number: ICV1248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 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: Death
• Patient Age: 54 YR