MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES ONX AORTIC ANATOMIC EXT 21; HEART-VALVE, MECHANICAL

Model Number ONXANE-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 08/21/2017

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 the implant recovery card (irc) received, (b)(6) male received onxane-21, sn (b)(4), on (b)(6) 2013 and required reintervention/explant on (b)(6) 2017 and subsequent replacement via onxa-19 due to undisclosed reason.Additional information is pending.

Manufacturer Narrative

Multiple requests to the surgeon for additional clarifying information were made without success to acquire the following information: patient¿s current status, indication for re-operation, available operative notes, patient impact, and pertinent patient co-morbidities.No response was received.The manufacturing records for the onxane-21, sn (b)(4), were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.  onxane-21, sn (b)(4) implanted on (b)(6) 2013 in (b)(6) male; explanted on (b)(6) 2017 (3 years 295 days postop) and replaced by onxa-19, sn (b)(4) as reported to manufacturer's device tracking registration database.The explanted valve was not returned to the manufacturer and no other information was made available.The instructions for use (ifu) note the risk of explantation as a consequence of a complication, but we have no information on what complication may have prompted the procedure.Consequently, there is not enough information to know what, if any, relationship the explantation has to the valve.The ifu lists the following as potential adverse events: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, myocardial infarction, prosthesis leaflet entrapment (impingement), prosthesis nonstructural dysfunction, prosthesis pannus, prosthesis perivalvular leak, prosthesis perivalvular leak, prosthesis regurgitation, prosthesis structural dysfunction, prosthesis thrombosis, stroke, and thromboembolism.It is possible that these complications could lead to reoperation and explantation.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the implant recovery card (irc) received, (b)(6) male received onxane-21, sn (b)(4), on (b)(6) 2013 and required reintervention/explant on (b)(6) 2017 and subsequent replacement via onxa-19 due to undisclosed reason.

• Brand Name: ONX AORTIC ANATOMIC EXT 21
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144
• MDR Report Key: 6926358
• MDR Text Key: 88997720
• Report Number: 1649833-2017-00075
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXANE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/11/2017
• Date Manufacturer Received: 09/11/2017
• 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; Other; Required Intervention
• Patient Age: 40 YR