MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

Model Number	ONXM-25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Artivion received notification of an onx mitral valve implant onxmc-25/33, sn (b)(6), implant date on (b)(6) 2014, for a patient with an existing onx mitral heart valve onxm-25, sn (b)(6), implant date on (b)(6) 2011.This investigation is relegated to onxm-25, sn (b)(6) for explant.
Event or Problem Description
Artivion received notification of an onx mitral valve implant onxmc-25/33, sn: (b)(6), implant date on (b)(6) 2014, for a patient with an existing onx mitral heart valve onxm-25, sn: (b)(6), implant date on (b)(6) 2011.This investigation is relegated to onxm-25, sn: (b)(6) for explant.Additional information received.Explant due to patient conditions.There is no alleged deficiency of the device.A complaint is ¿written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization¿s control or related to a service that affects the performance of such medical devices.¿ based on the information provided to artivion, there is no allegation of deficiency or resultant adverse event caused by the artivion product; therefore, further investigation and regulatory reporting into the event are not warranted.
Additional Manufacturer Narrative
Artivion received notification of an onx mitral valve implant onxmc-25/33, sn: (b)(6), implant date on (b)(6) 2014, for a patient with an existing onx mitral heart valve onxm-25, sn: (b)(6), implant date on (b)(6) 2011.This investigation is relegated to onxm-25, sn: (b)(6) for explant.Additional information received.Explant due to patient conditions.There is no alleged deficiency of the device.A complaint is ¿written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization¿s control or related to a service that affects the performance of such medical devices.¿ based on the information provided to artivion, there is no allegation of deficiency or resultant adverse event caused by the artivion product; therefore, further investigation and regulatory reporting into the event are not warranted.

• Brand Name: ONX MITRAL STANDARD 25
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 eas anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 20452648
• Report Number: 1649833-2024-00047
• Device Sequence Number: 15215115
• Product Code: LWQ
• UDI-Device Identifier: 00851788001273
• UDI-Public: 851788001273
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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
• Device Model Number: ONXM-25
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female