MAUDE Adverse Event Report: ARTIVION, INC. ON-X AAP UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number ONXAAP-23

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); Heart Block (4444); Unspecified Heart Problem (4454)

Event Date 12/06/2019

Event Type  Injury  

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.

Event Description

According to the adverse event report, serious adverse event, led to a serious deterioration in the health of the subject, users or other persons as defined by one of the following: medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.Start date december 6, 2019 end date december 9, 2019 outcome - symptoms resolved without sequelae.Causal relationship to procedure - probable.Causal relationship to the aortic valve disease of heterogeneous ethology - not related.Causal relationship to on-x aap - possible.Number of reoperations performed: reoperation is defined as an additional surgical procedure after the index procedure (implantation of on-x aap) targeted at the pathology that was initially treated using the on-x aap or targeted at a new pathology caused by the index procedure - 1.Comment on event and specify reason in case of ade or sade - not ade or sade.Date of reoperation - december 9, 2019.Days after intervention - 3.Main reason for reoperation - ppm implant.Is the reason for reoperation related to the intervention - probable.Is the reason for the reoperation related to the aortic valve disease of heterogeneous ethology - not related.Is the reason for reintervention related to on-x aap - possible.Explant of on-x aap - no.Outcome of the reoperation - symptoms resolved without sequelae.

Manufacturer Narrative

According to the adverse event report, serious adverse event, led to a serious deterioration in the health of the subject, users or other persons as defined by one of the following: medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.Start date (b)(6) 2019 end date (b)(6) 2019 outcome - symptoms resolved without sequelae causal relationship to procedure - probable causal relationship to the aortic valve disease of heterogeneous ethology - not related causal relationship to on-x aap - possible number of reoperations performed: reoperation is defined as an additional surgical procedure after the index procedure (implantation of on-x aap) targeted at the pathology that was initially treated using the on-x aap or targeted at a new pathology caused by the index procedure - 1 comment on event and specify reason in case of ade or sade - not ade or sade date of reoperation - (b)(6) 2019 days after intervention - 3 main reason for reoperation - ppm implant is the reason for reoperation related to the intervention - probable is the reason for the reoperation related to the aortic valve disease of heterogeneous ethology - not related is the reason for reintervention related to on-x aap - possible explant of on-x aap - no outcome of the reoperation - symptoms resolved without sequelae this investigation is relegated to onxaap-23 sn (b)(6).The product remains implanted and will not be returned to the manufacturer for evaluation.The manufacturing records for the onxaap-23 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.An onxaap 23 with serial number (b)(6) was implanted with concomitant procedure of the resection and replacement of the ascending aorta and proximal transverse aortic arch (beveled hemiarch with a 26 mm woven dacron tube graft) on 6dec2019 in a male of unknown age with a past medical history of ascending aortic aneurysm, aortic valve stenosis, hypertension and a bicuspid aortic valve.The subject was enrolled in the ascend study.On (b)(6) 2019 (3 days post implant) the patient had a dual chamber pacemaker implanted secondary to complete heart block.On (b)(6) 2019 (day of implant) the patient was transferred from the operating room to the intensive care unit with a cardiac rhythm of complete heart block he was paced with epicardial pacing wires [epw] in the icu.On (b)(6) 2019 (1-day post implant) his rhythm was recorded as junctional escape at 55 bpm with the pacer disconnected.On (b)(6) 2019 (2 days post implant) the pacer was reapplied and set to 50, the patient was noted to have increased work of breathing [wob] placed on bipap given 40mg of lasix iv and was also started on milrinone.On (b)(6) 2019 (3 days post implant) the patient remained in complete heart block, a procedure to place a permanent pacemaker was scheduled for the afternoon.The permanent pacemaker was placed in the catherization lab and the patient was transferred back to the icu.The patient continued to recover without additional events noted and was discharged home on (b)(6) 2019 (9 days post implant) with an inr of 1.9, on coumadin 4mg daily and lovenox injections with instructions to follow up with the inr clinic.The instructions for use [ifu] for the aap valve lists cardiac arrhythmia as a potential adverse event for mechanical prosthetic valve recipients.There is no indication that the on-x valve contributed in any way to the reported episode, and it is more likely a complication related to the surgical procedure itself rather than the valve.The arrhythmia event and pacemaker implantation is a probable consequence of the aortic valve replacement surgical procedure.The arrhythmia/pacemaker implantation is considered valve related as it occurred less than 14 days post aortic valve replacement.No further action is needed.Based on the available information, a definitive root cause for this event cannot be determined.However, the arrhythmia event and pacemaker implantation are a probable consequence of the aortic valve replacement surgical procedure.Additionally, without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.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: ON-X AAP UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC.; 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: 15765111
• MDR Text Key: 303395549
• Report Number: 1649833-2022-00055
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening