MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD EXT 19; HEART-VALVE, MECHANICAL

Model Number ONXAE-19

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Unspecified Heart Problem (4454); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.

Event Description

An implant registration card was received back from the user facility for a patient with an existing on-x aortic valve.This investigation will be relegated to onxae-19, sn (b)(4).Additional information has been requested.

Manufacturer Narrative

Additional information provided by artivion representative, stated, "i just spoke to [surgeon] assistant, and she told me it was just a matter of the kid growing out of the 19mm and needing the larger valve.All else was fine she said." per iso 13485:2016 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 cause by artivion product; therefore, further investigation is not warranted.

• Brand Name: ONX AORTIC STANDARD EXT 19
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw.; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15363059
• MDR Text Key: 299301429
• Report Number: 1649833-2022-00045
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXAE-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Male