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

Model Number	ART21SMT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
On december 19, 2016, the manufacturer was notified of the following: on (b)(6) 2016, a patient underwent a maze procedure and an avr.The valve was visually checked after implantation and no anomaly was observed.The tee was performed and no leak was confirmed.The patient's pre-operative platelet count was 194,000 units per microliter, the post-operative platelet count was 54,000 units per microliter, the 1st post-operative day platelet count was 46,000 units per microliter, and the 2nd post-operative day platelet count was 30,000 units per microliter.The patient then received a blood transfusion and the platelet count increased to 59,000 units per microliter and continued to increase gradually.The thrombocytopenia was not hit.
Additional Manufacturer Narrative
The partial manufacturing and material records for the solo smart heart valve, model #icv1247, s/n # (b)(4) were pulled and reviewed by quality control at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1247) solo smart heart valve at the time of manufacture and release.

• Brand Name: SOLO SMART HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6262530
• Report Number: 3004478276-2017-00003
• Device Sequence Number: 19039711
• Product Code: LWR
• UDI-Device Identifier: 00896208000467
• UDI-Public: (01)00896208000467(240)ICV1247(17)200502
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: Health Professional
• Device Expiration Date: 05/02/2020
• Device Model Number: ART21SMT
• Device Catalogue Number: ICV1247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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: Required Intervention
• Patient Age: 84 YR