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

Model Number	LXA23
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Stroke/CVA (1770)
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on this event through the patient tracking department.Based on the information provided, a patient was scheduled to undergo a tavr on (b)(6) or (b)(6) 2022.The patient received a mitroflow valve lxa23 on (b)(6) 2012 in aortic position.The day before the tavr procedure, the patient had a massive stoke.The patient survived, but is no longer suitable for the procedure.The patient had valve failure due to stenosis.The patient was transferred to a hospice care.

• Brand Name: MITROFLOW LXA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CROCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 14791432
• Report Number: 3019892983-2022-01037
• Device Sequence Number: 6108694
• Product Code: LWR
• UDI-Device Identifier: 00896208000115
• UDI-Public: (01)00896208000115(240)LXA23(17)161130
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2022
• Report Date (Section F): 05/30/2022

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: 11/30/2016
• Device Model Number: LXA23
• Device Catalogue Number: LXA23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2022
• Device Age: 10 YR
• Event Location: Home
• Date Report to Manufacturer: 05/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2022
• 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: Other
• Patient Age: 86 YR
• Patient Sex: Male