MAUDE Adverse Event Report: CORCYM CANADA CORP MITROFLOW 12A AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	LXA25
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition unknown, not returned.
Event or Problem Description
The manufacturer was informed on this event through the patient tracking department.Based on the information reported on the patient implant form, a mitroflow valve model lxa25 was implanted on (b)(6) 2012 and it was explanted on (b)(6) 2021.The manufacturer did not receive any allegation of a device malfunction nor of a serious injury for the patient from the hospital regarding this event.Per additional information received, the preoperative diagnosis indicated severe prosthetic aortic insufficiency and aortic stenosis of the mitroflow valve.The patient underwent a redo sternotomy, redo aortic valve replacement with a 23 inspiris pericardial valve.The procedure was performed uneventfully.Over the last year, the patient had multiple re-hospitalizations for heart failure and was noted to have a deteriorated prosthetic valve with severe aortic insufficiency and aortic stenosis.The patient was evaluated for a tavr and because of the low takeoff the coronary arteries, the patient was not deemed a candidate for the tavr procedure.Other history is notable for chronically occluded right hemidiaphragm and copd.
Additional Manufacturer Narrative
Fields updated: b4, b5, g3, g6, h1, h2, h6.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa25, s/n # (b)(6) as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa25 mitroflow aortic pericardial heart valve at the time of manufacture and release.Since the device was not received at the time of explant, and no further information on its disposition was provided, no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive conclusion for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.As reported in the scientific literature, structural valve deterioration is the major cause of failure of bioprosthetic heart valves.It should be noted that structural valve deterioration is listed as a possible adverse event in the mitroflow valve ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: MITROFLOW 12A AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 12192658
• Report Number: 3004478276-2021-00184
• Device Sequence Number: 4227374
• Product Code: LWR
• UDI-Device Identifier: 00896208000122
• UDI-Public: (01)00896208000122(240)LXA25(17)170228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 02/28/2017
• Device Model Number: LXA25
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR