MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	CNA
Medical Device Problem Codes	Occlusion Within Device (1423); Retraction Problem (1536); Folded (2630)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Thrombosis (2100); Thrombus (2101); Heart Failure (2206)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified on (b)(6) 2016 that a crown prt 19 was implanted on (b)(6) 2016, and the patient had an eventful post-operative stay and was discharged on (b)(6) 2016.The patient needed re-admission for heart failure on (b)(6) 2016.Transesophageal echocardiography showed severe thrombosis of the aortic valve.After anticoagulation therapy and proper optimal time management a new surgery was planned on (b)(6) 2016, showing retraction of the non coronary valve leaflet and no thrombosis.
Additional Manufacturer Narrative
Dec 21, 2016 design history record review: the complete manufacturing and material records for the crown prt aortic pericardial heart valve, model cna19, s/n (b)(4), were pulled and reviewed by quality control at livanova (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.After the incoming inspection, performed during the gross examination, a deformation of one leaflet almost folded down (in backflow direction) was observed.In order to investigate this topic, the valve was disassembled removing both the pericardial tissue and the dacron fabric paying attention to keep the correct correspondence of the posts and position.The deformed shape of the plastic stent has been confirmed (08 mar 2017).X-ray analysis was performed showing no calcifications.No abnormality on the tissue was identified.The crown stent was measured by means of a metrological system (ogp) and it was confirmed that it was conformant with a stent size 19 with regard to internal and external diameter.The stent showed a deformation at the posts level involving also the basis of the stent itself.Based on the clinical experience of the mitroflow valve, the plastic deformation of the stent might have been generated by a specific patient annulus anatomy or by a suboptimal valve implantation (tilting of the valve).
Event or Problem Description
Additional info received feb 15, 2017: the cause of the reintervention after the thrombosis solution was the early degeneration of the biological prosthesis which presented double aortic lesion with severe stenosis and moderate insufficiency.After the first intervention the patient wasn´t anti-coagulated.The surgeon¿s protocol in case of biological aortic prostheses in preserved sinus rhythm and lvef is the anti-aggregation with aspirin 100 mg / 24 h.The anticoagulation was initiated after the diagnosis of prosthetic thrombosis.The stent deformation was observed intraoperative, immediately before the explant.Patient's (b)(6).

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6064965
• Report Number: 3004478276-2016-00130
• Device Sequence Number: 1421089
• Product Code: DYE
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P060038/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 08/31/2020
• Device Model Number: CNA
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2016
• Supplement Report FDA Received Date: 04/05/2017
• 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: 72 YR
• Patient Weight: 83