MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ONX AORTIC ANATOMIC EXT 19; HEART-VALVE, MECHANICAL

Model Number ONXANE-19

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

Patient Problems Valvular Stenosis (2697); Insufficient Information (4580)

Event Date 09/26/2022

Event Type  Injury  

Event Description

An implant registration card for onxane-23 sn (b)(4), implanted (b)(6) 2022, was returned from the user facility for a patient with an existing on-x heart valve (onxane-19 sn (b)(4) implanted (b)(6) 2014.Both ircs notate the valves were implanted in the aortic position suggesting the onxane-19 sn (b)(4) was explanted.This investigation is relegated to onxane-19 sn (b)(4).

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

Manufacturer Narrative

According to initial reports, an implant registration card (irc) for onxane-23 sn (b)(6), implanted (b)(6) 2022, was returned from the user facility (uf) for a patient with an existing on-x heart valve (onxane-19 sn (b)(6)) implanted (b)(6) 2014.Both ircs notate the valves were implanted in the aortic position suggesting the onxane-19 sn (b)(6) was explanted.This investigation is relegated to onxane-19 sn (b)(6).The following additional information received: current patient status - alive and doing well with current inr at goal 1.5-2.Reason for surgical intervention - recurrent severe aortic stenosis due to prosthetic patient mismatch.Pertinent patient comorbidities - morbid obesity (bmi 43) sp h/o 2003 gastric bypass sp 2004 revisional roux-en-y gastric bypass, sle/ra on chronic oral steroids/antibiologics, htn, h/o endocarditis sp avr (19mm on-x), chronic anemia was there a deficiency with the explanted on-x valve - per op note "prior tissue valve was functioning with no large pannus, more ppm.Dense adhesions were encountered.Aortic root and annular enlargement required.¿ multiple attempts for product status have gone unmet.The product will not be returned to the manufacturer for evaluation.The manufacturing records for the onxane-19 sn (b)(6) 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.A review of the available information was performed.According to mandatory tracking information received by the manufacturer this patient was implanted with a second on-x valve in the aortic position 3,087 days after her initial implant.Onxace-19 sn (b)(6) was implanted on (b)(6) 2014 in the aortic position of a 46-year-old female patient.On (b)(6) 2023 we received the information that the second valve onxace -23 sn (b)(6) was implanted on (b)(6) 2022 in the aortic position.During the investigation we contacted the surgeon and were given the following information: the original valve was explanted and replaced due to ¿recurrent severe aortic stenosis due to ppm [patient prosthesis mismatch]¿ and ¿valve was functioning without a large pannus, more ppm.Dense adhesions were encountered.Aortic root and annular enlargement required¿.There was no claim regarding the valve having malfunctioned and all manufacturer records show review of manufacturing records show no processing issues.The valve was not returned to the manufacturer for examination.The instructions for use [ifu] for the on-x valve acknowledge the possibility of reoperation and explantation due to complications.Mis-sizing would fit in the classification of prosthesis nonstructural dysfunction, which is listed among the potential complications in the ifu.There is, however, no indication that the on-x valve failed to function as designed.It was simply the wrong size for this patient.Diagnosis of ppm [patient prosthesis mismatch] requiring the explant and subsequent implant of a larger size valve.There is no indication that the original on-x valve otherwise failed to perform as designed.No further action is required.A complaint and recall query was performed for onxane-19 sn (b)(6) to identify previously reported complaints or recalls associated with this complaint.No complaints or recalls were identified for this serial number.Based on the available information, ppm [patient prosthesis mismatch] requiring the explant and subsequent implant of a larger size valve.There is no indication that the original on-x valve otherwise failed to perform as designed.The manufacturing records 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.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion ¿ formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

• Brand Name: ONX AORTIC ANATOMIC EXT 19
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 16378991
• MDR Text Key: 309573894
• Report Number: 1649833-2023-00008
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001648
• UDI-Public: 851788001648
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXANE-19
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/18/2023
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female