MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 23; HEART VALVE MECHANICAL

Model Number ONXAAP-23

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Aortic Dissection (2491); Pericardial Effusion (3271)

Event Date 08/15/2017

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports, recipient of on-x conduit onxaap-23, patient expired (b)(6) 2017.A hospital representative communicated the following: patient had fragile x syndrome, multisystem organ failure, oxygen levels dropped, dnr.Date of death (b)(6) 2017.The hospital representative was unable to provide cause of death.According to operative notes (attached); preoperative diagnosis: dissection of the ascending aorta with a pericardia effusion postoperative diagnosis: dissection of the ascending aorta with extension into the right main coronary artery with mild aortic regurgitation and bloody pericardial effusion operation/procedure: bentall reconstruction of the aortic root and ascending aorta using a 23 mm on-x composite graft to reconstruct the aorta with reimplantation of the left main coronary artery, oversewing of the right main coronary artery with bypass from the graft to the right main coronary artery using a length of reverse autogenous saphenous vein graft from the left groin, reconstructing the ascending aorta with a 28 mm hemashield graft using moderately profound hypothermic total cardiopulmonary bypass and arrest with arterial cannulation of the right subclavian artery and venous cannulation of the right femoral and superior vena cava using intermittent cold blood retrograde cardioplegia for cardiac arrest anesthesia: general endotracheal anesthesia complications: none apparent at the completion of the procedure findings: as anticipated, the patient had dissection of the ascending aorta.Upon opening the aorta, the dissection appeared clean; that is, there was no obvious reentry point.The dissection seemed to be limited to the distal ascending and proximal arch.It did not appear grossly to involve the takeoffs of the cervical vessels.The right main coronary was dissected, and the intima completely came out of the artery when trying to reconstruct the button.The artery was oversewn and bypassed individually with a length of saphenous vein.At the completion of the procedure, contractility was preserved.There was about a 200-300 ml pericardial effusion when we opened the chest.There was no bleeding to explain this upon opening the chest, and no bleeding from the myocardium per se around the annulus as we came off pump.Poppets on the valve, which was a mechanical valve, appeared to work nicely.

Manufacturer Narrative

The manufacturing records for the (b)(4), sn (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.A review of the available information was performed.A (b)(6) year old male patient implanted with (b)(4), sn (b)(4), on (b)(6) 2017 indicated for dissection of the ascending aorta with pericardial effusion.The procedure performed was the "bentall reconstruction of the aortic root and ascending aorta using a 23 mm on-x composite graft to reconstruct the aorta with re-implantation of the left main coronary artery, over-sewing of the right main coronary artery with bypass from the graft to the right main coronary artery using a length of reverse autogenous saphenous vein graft from the left groin, reconstructing the ascending aorta with a 28 mm hemashield graft.¿ it was noted that the patient "tolerated the procedure well overall.He was transferred to the ccu (critical care unit) in stable but critical condition." additional information indicated that the patient expired on (b)(6)2017.The information regarding official cause of death was unavailable.The hospital reported that the patient had "fragile x syndrome, multisystem organ failure, oxygen levels dropped.Patient had dnr." no other information is available.It is unclear based on the available information the sequence of events preceding the patient death.However, it is likely that the patient death resulted from multisystem organ failure (unknown cause) and subsequent respiratory failure.The patient did not survive the surgery/recovery period, which classifies this as an early mortality, a subset of all-cause mortality [(b)(6) et al.2008]; but we have no information to support any conclusion as to whether or not it was valve related.The historical incidence of operative mortality after aortic valve replacement is (b)(4) [(b)(6) 2001].Death is a recognized risk of complications associated with prosthetic valve replacement [instructions for use].Root cause for this event is early mortality.There is not enough information to determine what, if any, relationship the death of the patient had to do with the valve.No further action is required at this time.

Event Description

According to initial reports, recipient of on-x conduit (b)(4), patient expired (b)(6) 2017.A hospital representative.Communicated the following: patient had fragile x syndrome, multisystem organ failure, oxygen levels dropped, dnr.Date of death (b)(6) 2017.The hospital representative was unable to provide cause of death.According to operative notes.Preoperative diagnosis: dissection of the ascending aorta with a pericardia effusion.Postoperative diagnosis: dissection of the ascending aorta with extension into the right main coronary artery.With mild aortic regurgitation and bloody pericardial effusion operation/procedure: bentall reconstruction of the aortic root and ascending aorta using a 23 mm on-x composite graft to reconstruct the aorta with reimplantation of the left main coronary artery, oversewing of the right main coronary artery with bypass from the graft to the right main coronary artery using a length of reverse autogenous saphenous vein graft from the left groin, reconstructing the ascending aorta with a 28 mm hemashield graft using moderately profound hypothermic total cardiopulmonary bypass and arrest with arterial cannulation of the right subclavian artery and venous cannulation of the right femoral and superior vena cava using intermittent cold blood retrograde cardioplegia for cardiac arrest anesthesia: general endotracheal anesthesia complications: none apparent at the completion of the procedure findings: as anticipated, the patient had dissection of the ascending aorta.Upon opening the aorta, the dissection appeared clean; that is, there was no obvious reentry point.The dissection seemed to be limited to the distal ascending and proximal arch.It did not appear grossly to involve the takeoffs of the cervical vessels.The right main coronary was dissected, and the intima completely came out of the artery when trying to reconstruct the button.The artery was oversewn and bypassed individually with a length of saphenous vein.At the completion of the procedure, contractility was preserved.There was about a 200-300 ml pericardial effusion when we opened the chest.There was no bleeding to explain this upon opening the chest, and no bleeding from the myocardium per se around the annulus as we came off pump.Poppets on the valve, which was a mechanical valve, appeared to work nicely.

• Brand Name: ONX ASCENDING AORTIC 23
• 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; kennesaw, GA 30144
• MDR Report Key: 7338321
• MDR Text Key: 102365235
• Report Number: 1649833-2018-00009
• 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: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/01/2019
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/08/2018
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 40 YR