MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 19; HEART-VALVE, MECHANICAL

Model Number ONXACE-19

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/02/2016

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, patient received first valve onxace-19 on (b)(6) 2016 and required intervention explant on (b)(6) 2016 and subsequent replacement via another onxace-19 for yet unknown reasons.

Manufacturer Narrative

Cryolife field assurance received an e-mail 11/01/2016 from on-x device tracking, containing the implant registration cards (irc) for onxace-19 (on-x prosthetic aortic valve with conform-x sewing ring) valve, serial number (sn) (b)(4) implanted (b)(6) 2016 in the aortic position and onxace-19 valve sn (b)(4) implanted (b)(6) 2016 in the mitral position.The following additional information was requested from the surgeon's office by phone 11/09/2016: was this a reoperation or did the patient receive two implants, one for mitral and one for aortic as the ircs suggest, if the second surgery was a reoperation could the following be provided: indication (reason) for re-operation, what was the patient impact, current patient status, pertinent patient co-morbidities, are implant operative notes available?.An additional phone call was placed to the doctor¿s office 11/10/2016.A message was left requesting the above-referenced information.Further correspondence of facsimile transmission and two day federal express delivery were sent 11/09/2016.All attempts at correspondence were unmet.Based on all available information, there is no allegation of deficiency being made to either on-x valve.Therefore, complaint (b)(4) will be voided.

Event Description

According to the implant registration card, patient received first valve onxace-19 on (b)(6) 2016 and required intervention explant on (b)(6) 2016 and subsequent replacement via another onxace-19 for yet unknown reasons.

• Brand Name: ONX AORTIC CONFORM EXT 19
• 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: 6132359
• MDR Text Key: 61033520
• Report Number: 1649833-2016-00076
• 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: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/01/2016
• Date Manufacturer Received: 11/01/2016
• 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
• Patient Age: 6 YR