MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXAE-23

Device Problem Partial Blockage (1065)

Patient Problems Embolism (1829); Thrombosis (2100)

Event Date 09/18/2016

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Initial notification from the distributor indicated the following: "as i believe you received message left on your mobile from mr.(b)(6), we have experienced an emergent on-x aortic valve replacement yesterday because of the valve leaflet dysfunction by blood clot with the patient at (b)(6).The detail report will be followed, but could you possibly tell me how and what container specifically we should use and return the removed valve to you for your investigation within today? the valve retrieved are now on the surgeons hand in formalin, but i have heard there are normally two way to send back to you in formalin or in dry by special container.What we would like you to see if the blood clot and how impact is was to cause the defective, so i guess the best way could be in formalin as much similar as in just after-removed condition.What would you think about it?" "the patient is male and (b)(6).Onx a-23 was implanted in 2010 and post-operative condition on the patient was stable.Follow-ups were executed annually after the primary surgery and along the way he has experienced stroke.Transported to hospital because of respiratory failure on (b)(6) 2016 when inr indicated 1.5.Echo diagnostic confirmed there was no opening and closing of the valve leaflets.Revision surgery was undertaken on the (b)(6) and aortic tissue valve was replaced.He has been stable postoperatively." additional information from the distributor stated the following: -indication for implant: "because of stuck by thrombus.Severe as and moderate ar were recognized.-pertinent patient comorbidities congested heart failure".-historic inr preceding event and at time of event: "at the discharge after the primary surgery : inr 3.10, at the event of failure : inr 1.50, pre-op of the revision this time: inr 2.16.At the discharge after the revision will come later." -was there a change in medication, medication compliance, or diet? "at the discharge after primary surgery : warfarin, at the pre-op of the revision : warfarin, heparin.Diet is unknown." -proposed etiology for thrombotic event: "unknown, unfortunately.".

Manufacturer Narrative

Additional info was received on 10/17/2016, ¿according to the doctor the patient is very serious type of person and understood his condition related to anti-coagulation.His inr has been controlled 2.0-2.5 as he had been suffered brain infarct after 6 months of avr [aortic valve replacement] operation in 2010.The inr at admission by emergency was 1.5.Thanks for small leakage space tiny blood flow through such space has been maintained¿ and also requested information regarding the source of the event.Clarification was requested from the distributor and was provided same day (answers by the distributor indicated in quotations).The patient was maintained on an inr of 2.0-2.5 and experienced a cerebral infarction approximately 6 months after implant.At the time of event, the patient presented to the emergency department with an inr of 1.5.Is this correct? ¿yes, correct.His inr was maintained on inr of 2.0-2.5 after cerebral infarction.But i do not know the level of inr before cerebral infarction.¿ can you clarify what "thanks for small leakage space tiny blood flow through such space has been maintained" means? ¿as the leaflets were not completely closed the patient was survive when he came to the emergency department.Meaning valve was not completely stuck.¿ clarification was requested from the distributor regarding the stroke (date of event and type of stroke) as well as a proposed cause for the respiratory failure occurring on (b)(6) 2016.The distributor responded same day ¿the date of the stroke (¿cerebral infarction¿ is maybe to be precise?) occurred on (b)(6) 2010, 4 months after the aortic valve 23mm was implanted on (b)(6) 2010.Regarding the root cause of respiratory failure, it must have been due to severe as and moderate ar.¿ the distributor provided documentation of patient inr history via email on (b)(6) 2016.The returned on-x valve was evaluated by the (b)(4) on 11/04/2016.The pathology report indicated the following: gross description: the specimen is received in an unlabeled container of formalin and consists of a single intact mechanical heart valve.The sewing ring remains intact with no visible sutures or adjacent soft tissue.The outside diameter of the entire valve, including the sewing ring is approximately 3 cm.The internal diameter is approximately 2 cm.The valve leaflets are non-mobile.The movement of the leaflets is impinged by numerous tan-brown vegetations presents on both pivot points.Thrombus is present on both the inflow and outflow surfaces of each leaflet.The thrombus is firmly adherent to the surface of the valve.Representative portions are submitted in a single cassette for histologic assessment.Microscopic description: representative sections of the vegetative material adherent to the valve leaflet shows fibrin mixed with red blood cells, occasional leukocytes, and macrophages.One section shows a distinctly different pattern of fibrin deposition that appears more solid with less red blood cell content, and also contains degenerative smudged nuclear material.Within the dense fibrin are multiple small islands of amorphous non-refractile material that has a bluish-gray appearance on h&e stain.Occasional macrophages with foamy cytoplasm are seen associated with the material.Final diagnosis: extensive thrombosis of valve pivot points resulting in immobilization of the valve leaflets in a partially open position.No acute inflammation or bacterial clusters to suggest endocarditis.Fragments of unidentified amorphous material, possibly foreign in nature.The manufacturing records for the onxae-23, sn (b)(4), 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.During the investigation no non-conformances or deviations were noted.The onxae-23, sn (b)(4), was implanted (b)(6) 2010.The patient suffered a stroke five months after implantation.Valve thrombus was diagnosed and the valve was explanted on (b)(6) 2016 (6 years 8 months postop).Thrombotic material observed via the provided pictures and the pathological report are present predominantly in both pivot hinge regions.As a result, the leaflet motion was severely restricted leaving a small, fixed opening which resulted in severe as and moderate ar expressed as respiratory failure.The restricted flow was confirmed by echo with a high pressure gradient and peak velocity.Echoes performed in the prior two years did not indicate restricted flow suggesting thrombus formed over the last year.The inr record over the years shows both super- and sub-therapeutic values.Inr at the time of explant was 1.5, the bottom end of acceptable inr range for single aortic on-x cases [puskas 2014, instructions for use].No mention was made concerning use of antiplatelet agents.The potential for chronic sub-therapeutic anticoagulation cannot be discounted.The recommended standard-of-care for single on-x mechanical valve replacement in the aortic position is inr 1.5-2.0 with 75-100mg aspirin daily, unless otherwise contraindicated.Prosthesis thrombosis and reoperation are also listed therein as a potential adverse events associated with prosthetic heart valves.A definitive root cause for the reported event cannot be determined however the thrombosed aortic valve may potentially be due to sub-therapeutic anticoagulation.Thrombosis is a monitored event in the dfmea.Additionally, thromboembolic events are an unexpected adverse event for mechanical valves.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Manufacturer Narrative

Class = "tableparagraph" style = "margin: 7.6pt 15.05pt 0.0001pt 3.7pt;" further additional information from the distributor conveyed by the physician indicated, "distributor that was conveyed by the surgeon who stated, ¿the patient was dosed with aspirin (babyaspirin) starting from (b)(6) 2016.However, it stopped on (b)(6) about a month later, because anemia was diagnosed on him.¿ the distributor stated, "according to the surgeon, it seems warfarin was also dosed while aspirin was discontinued, though we could not obtain the record." class = "tableparagraph" style = "margin: 7.6pt 15.05pt 0.0001pt 3.7pt;" the additional information was evaluated for pertinence.Based on the new evaluation, a supplemental follow-up is being submitted in an abundance of caution.& nbsp; class = "tableparagraph" style = "margin: 0in 7.9pt 0.0001pt 3.7pt;" "babyaspirin" (probably "baby aspirin", i.E.75-100mg, typically administered daily) begun (b)(6) , but stopped (b)(6) 2016 due to anemia.Respiratory failure reported (b)(6) 2016 with valve explanted (b)(6) 2016.Explant showed thrombus formations in pivot regions severely restricting leaflet motion.Echo of (b)(6) 2015 (less than one year prior to explantation) indicated peak velocity and mean gradient typical of normal on-x valve operation.& nbsp; pathology report of thrombus material observed red cells captured within.& nbsp; both observations suggest the thrombus is of recent origin.The aspirin administration experience may or may not have contributed to the genesis of the thrombus, but its timing is suggestive.Indeed, it confirms that the patient was not taking an aspirin at the time of the adverse event while the inr was at the low end of the recommended range.Class = "tableparagraph" style = "margin: 0in 7.9pt 0.0001pt 3.7pt; the original assessment was thrombosed aortic valve potentially due to sub-therapeutic anticoagulation.& nbsp; if anything, the new information adds credence to this assessment.& nbsp; the conclusion, therefore, remains the same.This investigation is currently ongoing.& nbsp; any additional information will be provided in the follow-up report.& nbsp; 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 & nbsp; furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife & nbsp.

Event Description

Initial notification from the distributor indicated the following: "as i believe you received message left on your mobile from [distributor], we have experienced an emergent on-x aortic valve replacement yesterday because of the valve leaflet dysfunction by blood clot with the patient at hyogo brain and heart center.The detail report will be followed, but could you possibly tell me how and what container specifically we should use and return the removed valve to you for your investigation within today? the valve retrieved are now on the surgeons hand in formalin, but i have heard there are normally two way to send back to you in formalin or in dry by special container.What we would like you to see if the blood clot and how impact is was to cause the defective, so i guess the best way could be in formalin as much similar as in just after-removed condition.What would you think about it?" "the patient is male and (b)(6) years old.Onx a-23 was implanted in 2010 and post-operative condition on the patient was stable.Follow-ups were executed annually after the primary surgery and along the way he has experienced stroke.Transported to hospital because of respiratory failure on (b)(6) 2016 when inr indicated 1.5.Echo diagnostic confirmed there was no opening and closing of the valve leaflets.Revision surgery was undertaken on the (b)(6) and aortic tissue valve was replaced.He has been stable postoperatively.Additional information from the distributor stated the following: indication for implant: "because of stuck by thrombus.Severe as and moderate ar were recognized.Pertinent patient comorbidities congested heart failure.Historic inr preceding event and at time of event: "at the discharge after the primary surgery: inr 3.10, at the event of failure: inr 1.50, pre-op of the revision this time: inr 2.16.At the discharge after the revision will come later." was there a change in medication, medication compliance, or diet? "at the discharge after primary surgery: warfarin, at the pre-op of the revision: warfarin, heparin.Diet is unknown." proposed etiology for thrombotic event: "unknown, unfortunately." further additional information from the distributor conveyed by the physician indicated, "distributor that was conveyed by the surgeon who stated, ¿the patient was dosed with aspirin (babyaspirin) starting from (b)(6) 2016.However, it stopped on (b)(6) about a month later, because anemia was diagnosed on him.¿ the distributor stated, "according to the surgeon, it seems warfarin was also dosed while aspirin was discontinued, though we could not obtain the record.".

• Brand Name: ONX AORTIC STANDARD EXT 23
• 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 nw; kennesaw, GA 30144
• MDR Report Key: 6057638
• MDR Text Key: 58404407
• Report Number: 1649833-2016-00067
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXAE-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/27/2016
• Date Manufacturer Received: 07/31/2017
• 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): Hospitalization; Other
• Patient Age: 68 YR