MAUDE Adverse Event Report: LIVANOVA CANADA CORP CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	CNA23
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Angina (1710); Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Mitral Insufficiency (1963); No Information (3190)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted (tavi performed).
Event or Problem Description
It was reported that a crown pericardial aortic heart valve was implanted on (b)(6) 2014.A tavi was performed on (b)(6) 2018 due to structural valve deterioration.No other information was provided.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model#: cna23, s/n#: (b)(4) , as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.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.Based on the document review performed, no manufacturing deficits were identified.The patient's medications are indicative of hypertension and hyperlipidemia, and possible kidney dysfunction, which can contribute to structural valve deterioration.As such, it is possible that the patient's clinical conditions and risk factors contributed to the reported event.However, as the device was not explanted, no device investigation can be conducted and the root cause of the event ultimately cannot be determined.Updated fields: event, other relevant history.
Event or Problem Description
A crown cna23 was implanted on (b)(6) 2014.Four years later, a corevalve evolut r pro was implanted via tavi due to svd.Prior to the tavi on (b)(6) 2018), the patient's mean gradient was 60 mmhg.The patient also had dyspnea and angina pectoris disease, and was classified as ccs iii (for angina pectoris) and nyha iii, after having stented the rca in march 2018.Pre-tavi echocardiography on (b)(6) 2018 revealed moderately sclerosed aortic valve pockets with severely restricted opening, grade iii aortic valve stenosis, and slight aortic insufficiency.The mitral ring was also calcified, with slightly sclerosed leaflets, no stenosis, and moderate mitral insufficiency.The tricuspid and pulmonary valves, as well as the aorta, were unremarkable.Post-operatively, the mean gradient was 36 mmhg.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7630543
• Report Number: 3004478276-2018-00223
• Device Sequence Number: 11365710
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)190831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 08/31/2019
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: 67 YR