MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

Model Number ONXM-25

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hypoxia (1918); Pulmonary Edema (2020); Cardiogenic Shock (2262)

Event Date 11/30/2021

Event Type  Injury  

Event Description

According to the initial report received, "i have received notification from [user facility] this morning that they are undertaking an emergency explant of an on-x mitral valve onm-25 (implanted (b)(6) 2020 at [user facility] - s/n (b)(4)) due to missing leaflet.I don¿t have any further details at this stage ¿ they are currently trying to find and recover the missing leaflet.Can you please advise next steps and information required asap for progressing the follow up and anyone else that needs to be notified.I will keep you posted with any further developments and updates as they come through." additional information stated, "patient was playing on large waterslide on (b)(6).Then was at a creek swimming on the afternoon of (b)(6) and doing some jumping (bombing) into water off a tree/log.Felt short of breath in car on way home.Could barely walk/get out of car.Patient developed acute pulmonary edema and developed cardiogenic shock and hypoxia.Required emergency surgery on admission to hospital.One leaflet found to be missing from valve.Patient scanned 2 days later and valve leaflet was found to be fractured into 2 parts ¿ approx.70% in abdominal aortic bifurcation and remainder in right iliac artery.After consultation with vascular surgeons it has been decided to leave the fractured valve pieces in situ currently." additional information stated, "quick update firstly (and most importantly) patient is doing well! the leaflet has been found in the iliac artery ¿ they are most likely going to leave it there as it appears not to be occluding the vessel.I¿m calling into the hospital this afternoon to collect the valve and completed form (subject to acutes and availability of the charge nurse) will instigate the nz medsafe process and then return completed data to cryolife along with the valve.Will keep you posted" another update stated, "patient is stable in icu.Valve leaflet was fractured and both portions remain in situ currently following advice from the vascular surgeons.We have also submitted the same information to our regulatory body in nz ¿ medsafe" this investigation will be relegated to onxm-25, sn (b)(6).The valve will be returned for evaluation.

Event Description

According to the initial report received, "i have received notification from [user facility] this morning that they are undertaking an emergency explant of an on-x mitral valve onm-25 (implanted (b)(6) 2020 at [user facility] - s/n (b)(4)) due to missing leaflet.I don¿t have any further details at this stage ¿ they are currently trying to find and recover the missing leaflet.Can you please advise next steps and information required asap for progressing the follow up and anyone else that needs to be notified.I will keep you posted with any further developments and updates as they come through." additional information stated, "patient was playing on large waterslide on (b)(6).Then was at a creek swimming on the afternoon of (b)(6) and doing some jumping (bombing) into water off a tree/log.Felt short of breath in car on way home.Could barely walk/get out of car.Patient developed acute pulmonary edema and developed cardiogenic shock and hypoxia.Required emergency surgery on admission to hospital.One leaflet found to be missing from valve.Patient scanned 2 days later and valve leaflet was found to be fractured into 2 parts ¿ approx.70% in abdominal aortic bifurcation and remainder in right iliac artery.After consultation with vascular surgeons it has been decided to leave the fractured valve pieces in situ currently." additional information stated, "quick update firstly (and most importantly) patient is doing well! the leaflet has been found in the iliac artery ¿ they are most likely going to leave it there as it appears not to be occluding the vessel.I¿m calling into the hospital this afternoon to collect the valve and completed form (subject to acutes and availability of the charge nurse) will instigate the nz medsafe process and then return completed data to cryolife along with the valve.Will keep you posted" another update stated, "patient is stable in icu.Valve leaflet was fractured and both portions remain in situ currently following advice from the vascular surgeons.We have also submitted the same information to our regulatory body in nz ¿ medsafe" this investigation will be relegated to onxm-25, sn (b)(6).The valve will be returned for evaluation.

Manufacturer Narrative

The manufacturer was notified that the fractured leaflet was recovered from the previously explanted valve onxm-25 sn # (b)(6) that was implanted on (b)(6) 2020.The leaflet was recovered from the patient, decontaminated at the hospital and then returned to the manufacturer for inspection.On 14june2023 a sample evaluation was performed on the fractured leaflet pieces.The conclusion was that the leaflet fracture appears to be related to damage generated by contact and manipulation with a metallic instrument.The examination of the explanted leaflets revealed that the leaflet fracture appeared related to forces generated by contact and manipulation with a metallic instrument.The root cause for this event is forces generated by contact and manipulation with a metallic instrument as found during the evaluation of the fractured leaflet pieces.There is no indication that an error or deficiency occurred at artivion and all risks identified have been mitigated as far as possible and residual risk is acceptable.The ifu explains that the leaflets should not be handled with metallic instrumentation.Field assurance 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 is accurate or has been confirmed by artivion.

Event Description

According to the initial report received, "i have received notification from [user facility] this morning that they are undertaking an emergency explant of an on-x mitral valve onm-25 (implanted (b)(6) 2020 at [user facility] - s/n (b)(6)) due to missing leaflet.I don¿t have any further details at this stage ¿ they are currently trying to find and recover the missing leaflet.Can you please advise next steps and information required asap for progressing the follow up and anyone else that needs to be notified.I will keep you posted with any further developments and updates as they come through." additional information stated, "patient was playing on large waterslide on 27/11.Then was at a creek swimming on the afternoon of 29/11 and doing some jumping (bombing) into water off a tree/log.Felt short of breath in car on way home.Could barely walk/get out of car.Patient developed acute pulmonary edema and developed cardiogenic shock and hypoxia.Required emergency surgery on admission to hospital.One leaflet found to be missing from valve.Patient scanned 2 days later and valve leaflet was found to be fractured into 2 parts ¿ approx.70% in abdominal aortic bifurcation and remainder in right iliac artery.After consultation with vascular surgeons it has been decided to leave the fractured valve pieces in situ currently." additional information stated, "quick update firstly (and most importantly) patient is doing well! the leaflet has been found in the iliac artery ¿ they are most likely going to leave it there as it appears not to be occluding the vessel.I¿m calling into the hospital this afternoon to collect the valve and completed form (subject to acutes and availability of the charge nurse) will instigate the nz medsafe process and then return completed data to cryolife along with the valve.Will keep you posted" another update stated, "patient is stable in icu.Valve leaflet was fractured and both portions remain in situ currently following advice from the vascular surgeons.We have also submitted the same information to our regulatory body in nz ¿ medsafe" this investigation will be relegated to onxm-25, sn (b)(6).The valve was evaluated.The escaped fractured leaflet pieces were returned and evaluated on 14june2023.

• Brand Name: ONX MITRAL STANDARD 25
• 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 ; 7704193355
• MDR Report Key: 13060545
• MDR Text Key: 285537393
• Report Number: 1649833-2021-00046
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001273
• UDI-Public: 851788001273
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• 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): Life Threatening; Other