MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS 27/29MM; HEART-VALVE, MECHANICAL

Model Number ONXAAP-27/29

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

Patient Problems Organ Dehiscence (2502); No Information (3190)

Event Date 11/04/2016

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 registration card, (b)(6) yo patient received onxaap-27/29 (sn (b)(4))on (b)(6) 2014 and required intervention/explant on (b)(6) 2016 and replacement with another onxaap-27/29.Explant reported by hospital for "revision/upgrade.".

Manufacturer Narrative

Note: (b)(6).Additional information received from the nurse stated that the indication for re-intervention/explant was ¿dehiscence of the aortic root¿ but an etiology was not specified.The procedure was successfully completed but no other details were provided.The manufacturing records for the onxaap-27/29, 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.The onxaap-27/29, sn (b)(4), was implanted (b)(6) 2014 and explanted/replaced with another onxaap-27/29 on (b)(6) 2016 (2 years 89 days postop).Reports from the explanting site state the reasons for explant were "revision/upgrade" and "dehiscence of the aortic root." the first reason doesn't tell us anything useful but the second suggests that the valve cuff was separating from the aortic annular tissue.How this was diagnosed or what symptoms led to the decision to replace, actual location of the separation and its severity, are not given, nor is there any indication of the precipitating cause of the separation.No mention is made of tissue viability or of suture/cuff integrity.The replacement procedure, nevertheless, was successfully completed.There is not enough detailed information to indicate what, if any, relationship the dehiscence has to the valve.The precipitating cause, in particular, remains unknown.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the implant registration card, 29.(b)(6) patient received onxaap-27/29 (sn (b)(4)) on (b)(6) 2014 and required intervention/explant on (b)(6) 2016 and replacement with another onxaap-27/29.Explant reported by hospital for "revision/upgrade.".

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS 27/29MM
• 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
• MDR Report Key: 6264461
• MDR Text Key: 65301731
• Report Number: 1649833-2017-00007
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXAAP-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/21/2016
• Date Manufacturer Received: 12/21/2016
• 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; Other
• Patient Age: 29 YR