MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE AND EXTENDED HOLDER 23MM; MECHANICAL HEART VALVE

Model Number ONXAE-23

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

Patient Problems Fistula (1862); Complaint, Ill-Defined (2331); No Information (3190); No Code Available (3191)

Event Date 07/27/2016

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 the implant recovery card, patient implanted with onxae-23 (b)(4) on (b)(6) 2016 and required reoperation/explant on (b)(6) 2016.Replaced with onxae-21.

Manufacturer Narrative

According to the implant registration cards (irc) provided on 08/11/2016, the patient had surgery on (b)(6) 2016 and had onxae-23 sn (b)(4) implanted.On (b)(6) 2016, onxae-23 sn (b)(4) was removed and an onxae-21 sn (b)(4) was implanted.Additional information via operative notes were requested and received via fax on 09/26/2016.These operative notes were reviewed by the medical director and the following memo was created: operative notes received indicate the following regarding explant of the initial valve 8 days post-op ((b)(6) 2016) - "the pre-intraoperative transesophageal echocardiogram seemed to indicate a fistula between the aorta and the right atrium.This is indeed what we found.Because i had very extensively decalcified the aortic annulus, there was a small area in the ascending aorta, the aortic root that i had oversewn.This area was nice and loose and, as mentioned earlier, i had used a smaller valve to minimize the stress and on 2 subsequent echocardiograms, it actually looked very nice.This area, he had torn the aortic root adjacent to this repair and had torrential flow into his right atrium: and "the valve was, indeed, seated very well with no evidence of dehiscence whatsoever.It was obvious that there was a large defect just under the right coronary ostium draining into the right atrium.The previously placed valve was removed." based on this information, there is no indication that the reported events/explant are related to the on-x valve and no allegation of deficiency is made.Therefore, complaint (b)(4) will be voided.

Event Description

According to the implant recovery card, patient implanted with onxae-23 ((b)(4)) on (b)(6) 2016 and required reoperation/explant on (b)(6) 2016.Replaced with onxae-21.

• Brand Name: ON-X AORTIC HEART VALVE AND EXTENDED HOLDER 23MM
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5910628
• MDR Text Key: 53378165
• Report Number: 1649833-2016-00041
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/29/2022
• Device Model Number: ONXAE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 50 YR