MAUDE Adverse Event Report: ARTIVION, INC. - AUSTIN ONX ASCENDING AORTIC 19; HEART-VALVE, MECHNAICAL

Model Number ONXAAP-19

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

Patient Problems Pseudoaneurysm (2605); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2022

Event Type  Injury  

Event Description

According to the implant registration card returned for an onxaap - 23, the patient had the onxaap - 23 implanted in the aortic position on (b)(6) 2022.The on-x device tracking system showed this patient had a onxaap - 19 implanted on (b)(6) 2020 in the aortic position.This investigation is relegated to the onxaap-19 serial number: (b)(4).

Event Description

According to the implant registration card returned for an onxaap - 23, the patient had the onxaap - 23 implanted in the aortic position on (b)(6) 2022.The on-x device tracking system showed this patient had a onxaap - 19 implanted on (b)(6) 2020 in the aortic position.This investigation is relegated to the onxaap-19 serial number:(b)(6).Operative notes for (b)(6) 2022 procedure received from the hospital relayed a contained rupture/severe dehiscence of the posterior root with expanding pseudoaneurysm.In (b)(6) 2020, presented with aortic valve endocarditis and root abscess, at which time the patient underwent mechanical valve conduit implantation with reconstruction of the aortomitral continuity.No additional information forthcoming.The date of implant was corrected upon receipt of the operative notes.

Manufacturer Narrative

The manufacturing records for sn 6760502 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.On (b)(6) 2020 an onxaap-19 sn (b)(6) was used in a case for a 30-year-old female and a second onxaap was reported to device tracking for the same patient: (b)(6) 2022 onxaap- 23 sn (b)(6) (932 days post-implant).The implanting surgeon was contacted for further information and source medical records of the second implant on (b)(6) 2022 were provided.The original onxaap- 19 was not returned to the manufacturer for evaluation.On (b)(6) 2020 the initial onxaap-19 was implanted in a 30-year-old female patient with a past medical history of end-stage renal disease, first diagnosed at age 13, requiring hemodialysis status post failed transplant with nephrectomy in 2009 for recurrent pyelonephritis, hepatitis c, and history of cocaine abuse.The initial implant was to treat aortic valve endocarditis and root abscess.She underwent mechanical valve conduit implantation with reconstruction of the aortomitral continuity followed soon after by a ppm implantation and in (b)(6) 2020 a plug placement along the aortic annulus without significant success to treat significant posterior dehiscence of the attachments to the lvot.On (b)(6) 2022 she underwent an explant of the onxaap-19, and it was replaced with an onxaap-23 sn (b)(6) due to a contained rupture and severe dehiscence of the posterior aortic root with expanding pseudoaneurysm and concomitant coronary artery bypass graft (cabg x 1).The surgeon first met with the patient in (b)(6) 2021 and felt surgical intervention was appropriate, although would be a significantly high risk.Eventually the patient was agreeable, and they were able to proceed with the explant and replacement on (b)(6) 2022.The patient was discharged home on (b)(6) 2022 and no further follow up documentation was provided.The instructions for use [ifu] note that reoperation is a risk and lists false aneurysm as a potential adverse event.The pseudoaneurysm in this case along with the dehiscence of the posterior aortic root precipitated the reoperation.The development of a false aneurysm, a known potential complication, requiring repair of the aortic root necessitated the reoperation and admission.In addition, the repeated complications related to the dehiscence of the attachment to the lvot also contributed to the need for a re-do operation in this case.There is no indication that the on-x valve contributed to the reported episode.A review of the device history record (dhr) was acceptable with the final product meeting all specifications.The development of a false aneurysm, a known potential complication, requiring repair of the aortic root necessitated the reoperation and admission.In addition, the repeated complications related to the dehiscence of the attachment to the lvot also contributed to the need for a re-do operation in this case.There is no indication that the on-x valve contributed to the reported episode; thus, severity and occurrence is not evaluated.No further action is required.The development of a false aneurysm, a known potential complication, requiring repair of the aortic root necessitated the reoperation and admission.In addition, the repeated complications related to the dehiscence of the attachment to the lvot also contributed to the need for a re-do operation in this case.There is no indication that the on-x valve contributed to the reported episode.A review of the device history record (dhr) was acceptable with the final product meeting all specifications.There is no indication that an error or deficiency occurred at artivion formerly cryolife/jotec and all risks identified have been mitigated as far as possible and residual risk is acceptable; therefore, a capa is not warranted at this time.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 is accurate or has been confirmed by artivion.B5: correct date of implant.D6b: correct implant date.E1: correct last name.H 10: statement left off - 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 is accurate or has been confirmed by artivion.

• Brand Name: ONX ASCENDING AORTIC 19
• Type of Device: HEART-VALVE, MECHNAICAL
• 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. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 16013442
• MDR Text Key: 305786482
• Report Number: 1649833-2022-00070
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001501
• UDI-Public: 851788001501
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Model Number: ONXAAP-19
• Device Catalogue Number: ONXAAP-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/12/2022
• Date Manufacturer Received: 12/12/2022
• Date Device Manufactured: 08/01/2017
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female