MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART-VALVE, MECHANICAL

Model Number ONXAAP-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematemesis (4478)

Event Date 07/12/2018

Event Type  Injury  

Event Description

According to the initial report received, "patient is in the post-market clinical follow-up study protocol of the on-x ascending aortic prosthesis (aap) retrospective study and was implanted on (b)(6) 2012 with a prefabricated aap device sn # (b)(6), on (b)(6) 2018 (2,080 days post implant) presented to the ed with complaints of bloody stools for less than 12 hours.Pt had underwent a colonoscopy with polypectomy on 10jul2018.He was admitted for observation and placed on lmwh and discharged on (b)(6) 2018.He then returned to the ed on 17july2018 as his inr was 7.4 on routine monitoring.He reported diarrhea that was black and being lightheaded when standing, heart racing and associated chest tightness.Hgb in ed was 7.8 and on 12july2018 it was 13.2, his inr was 2.9 on admission to the ed.He was infused 1 unit prbc¿s in the ed and admitted for observation.He was discharged home on (b)(6) 2018 to follow up in 1-2 weeks.".

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- formerly cryolife/jotec is accurate or has been confirmed by artivion.

Manufacturer Narrative

Per the adjudication received, this event is not valve related.Per medical device reporting for manufacturers - fda guidance for industry and food and drug administration staff, section 2.16 an mdr report is not required when "you have information that would enable a person who is qualified to make a medical judgment to reasonably conclude that your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur." therefore, further investigation is not warranted.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• 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 blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18586798
• MDR Text Key: 333841364
• Report Number: 1649833-2024-00007
• 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
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other