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

Model Number ONXANE-23

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Vascular Dissection (3160)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Implant registration cards received indicate patient implanted on (b)(6) 2017 with both an onxane-21 sn (b)(4) and onxane-23, sn (b)(4) in the aortic position.This investigation is relegated to the onxane-23.Additional information via operative notes indicate that both attempts at implant were unsuccessful.A patient with severe aortic stenosis and severe aortic insufficiency was sized for the onxane-23, sn (b)(4), "however , the valve could not be successfully advanced past the sinotubular junction.Efforts to implant the 23 mm valve and manipulations necessary to implant the 21 mm valve [investigated separately] resulted in inadvertent partial thickness destruction of the aortic wall adjacent to the right coronary artery.".

Manufacturer Narrative

The manufacturing records for the onxane-23 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.The onxane-23 sn (b)(4) implant attempted (b)(6) 2017 in the aortic position of (b)(6) year old female.The surgeon could not get the valve to seat properly despite sizer indicating otherwise.The valve was removed and replaced with onxane-21 sn (b)(4).Annular tissue reconstruction resulted in positioning of the valve such that there was possible inadequate clearance for the left main coronary ostium and particularly for the right main coronary ostium.This valve was also removed and patient received a medtronic hancock ii porcine bioprosthesis which seemed to provide the necessary clearance.The operative report was made available.There are two parts to this complaint.The first is the mis-sizing and the second is the ostia clearance.For the first, the surgeon says the sizer fit, but the corresponding valve did not.It is not clear whether the surgeon sized for the valve before or after placement of the sutures.This matters because suture placement, especially pledgeted sutures, can affect the actual annulus diameter and subsequent valve fit.After feedback from the field, on-x now manufactures a second set of sizers to take pledgets into account and it is surgeon preference as to which set is used.The record made available to us does not indicate which set was used for this case.For the second part, reconfiguration of a surgically altered annulus resulted in an unusual anatomical shape rendering abnormal positioning of the coronary ostia relative to valve placement.The ostia were, in effect, lower than normal.Root cause for this event is mis-sizing of the valve annulus and the reshaped annulus created an abnormal positioning of coronary ostia relative to valve placement.No further action warranted on coronary ostia blockage issue due to unusual anatomy.

Event Description

Implant registration cards received indicate patient implanted on (b)(6) 2017 with both an onxane21 sn (b)(4) and onxane23, sn (b)(4) in the aortic position.Note: this investigation is relegated to the onxane23 additional information via operative notes indicate that both attempts at implant were unsuccessful.A patient with severe aortic stenosis and severe aortic insufficiency was sized for the onxane23, sn (b)(4), "however , the valve could not be successfully advanced past the sinotubular junction.Efforts to implant the 23 mm valve and manipulations necessary to implant the 21 mm valve [investigated separately] resulted in inadvertent partial thickness destruction of the aortic wall adjacent to the right coronary artery.".

• Brand Name: ON-X AORTIC ANATOMIC EXT 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: 6413022
• MDR Text Key: 70301313
• Report Number: 1649833-2017-00026
• 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: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/17/2017
• Date Manufacturer Received: 02/17/2017
• 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; Required Intervention
• Patient Age: 56 YR