MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART VALVE MECHANICAL

Model Number ONXACE-27/29

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Aortic Insufficiency (1715); Atrial Fibrillation (1729); No Code Available (3191)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to implant registration cards (b)(6) year-old male patient received onxace-27/29 (sn (b)(4)) on (b)(6) 2017 and required replacement with an onxace-25 on (b)(6) 2017.Additional information is pending.

Manufacturer Narrative

Operative notes and correspondence from the surgeon were received 02/28/2017.The following information was included with the cover letter regarding onxace-27/29 sn (b)(4); ¿the patient is a (b)(6) engineer with severe aortic valvular regurgitation with moderate lv impairment, atrial fibrillation, and hypertension referred for aortic valve replacement.He had aortic valve replacement with an on-x 27/29 prosthesis on (b)(6) 2017: the initial implant was uneventful with no difficulty in excising the native aortic valve leaflets, minimal annular debridement, straightforward sizing, and easy seating of the prosthetic valve.He had concomitant tricuspid annuloplasty for significant functional tricuspid regurgitation.However, there was intractable bleeding from the friable aortic root after weaning from cardiopulmonary bypass that was not controlled by patching the aortic root from outside or from within.' accordingly, the normally functioning on-x prosthesis was explanted to allow more extensive patching of the lv outflow tract, implantation of another smaller on-x prosthesis (on-x 25, serial no.(b)(4)), and hemi-aortic root replacement.The patient made steady progress on our critical care unit and cardiothoracic ward and has been discharged home.In particular, the valve was not explanted for any valve failure, but because of difficulties dealing with bleeding from a friable aorta.Per-operative trans-oesophageal echocardiography confirmed normal prosthetic valve function of the explanted on-x 27/29 and the final on-x 25 valves.¿ based on the information obtained from the surgeon, there is no allegation of deficiency or report of adverse patient impact.Therefore, this complaint will be voided. .

Event Description

¿the patient is a (b)(6) engineer with severe aortic valvular regurgitation with moderate lv impairment, atrial fibrillation, and hypertension referred for aortic valve replacement.He had aortic valve replacement with an on-x 27 /29 prosthesis on (b)(6) 2017: the initial implant was uneventful with no difficulty in excising the native aortic valve leaflets, minimal annular debridement, straightforward sizing, and easy seating of the prosthetic valve.He had concomitant tricuspid annuloplasty for significant functional tricuspid regurgitation.However, there was intractable bleeding from the friable aortic root after weaning from cardiopulmonary bypass that was not controlled by patching the aortic root from outside or from within.Accordingly, the normally functioning on-x prosthesis was explanted to allow more extensive patching of the lv outflow tract, implantation of another smaller on-x prosthesis (on-x 25, serial no.(b)(4)), and hemi-aortic root replacement.The patient made steady progress on our critical care unit and cardiothoracic ward and has been discharged home.In particular, the valve was not explanted for any valve failure, but because of difficulties dealing with bleeding from a friable aorta.Per-operative trans·oesophageal echocardiography confirmed normal prosthetic valve function of the explanted on-x 27/29 and the final on-x 25 valves.¿.

• Brand Name: ONX AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• 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: 6394726
• MDR Text Key: 69622593
• Report Number: 1649833-2017-00024
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/09/2017
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 55 YR