MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE - 19MM; HEART-VALVE, MECHANICAL

Model Number ONXA-19

Device Problem Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Complaint, Ill-Defined (2331)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the initial report from the distributor, "could you possibly arrange to send another ¿return kit for explanted valve¿ to me again? this is because we have received a new case with on-x valve stuck and revision surgery has been underwent.The following is the initial information and a lot more is coming later." a (b)(6) yo female previously underwent aortic valve replacement (avr) and mitral valvuloplasty (mvp) with placement of onxa-19 (sn (b)(4)) on (b)(6) 2006.Intervention was required, "the doctor has found that one side of the leaflets did not partially open when outflowed in (b)(6) 2016 and planned to conduct reoperation in (b)(6) [2016].It is a completely planned reoperation." intervention and explant of valve was performed on (b)(6) 2016.Current patient status reported as "alive and getting better." additional information from the distributor indicated the following: "according to the surgeon¿s comment, the both leaflets were interfered by pannus from infra side causing non-full open.Though, there is no attaching materials or else on the returned valve and no evidence about the pannus interference, surgeon said the cause was pannus.He said he will send us the photo taken while the re-do surgery, in short." the initially referenced photos are for review despite a lack of gross evidence of pannus.Intraoperative photos from the intervention have not been provided.The sample has been returned and is being evaluated.

Manufacturer Narrative

Additional information from the distributor included the following: ¿according to the surgeon¿s comment, the both leaflets were interfered by pannus from infra side causing non-full open.Though, there is no attaching materials or else on the returned valve and no evidence about the pannus interference, surgeon said the cause was pannus.He said he will send us the photo taken while the re-do surgery, in short¿ and "according to the surgeon, it is highly likely that the pannus interfered the normal movement of the leaflet and smooth blood flow leading the patient to the congested heart failure and the revision surgery this time.¿ the valve was returned and a pathology evaluation was performed.The specimen consists of an intact bileaflet mechanical heart valve measuring 17 mm in internal diameter.The leaflets are freely moveable with no evidence of thrombosis or other impingement on the hinge mechanism.The attached sewing ring is intact and contains a small amount of tissue that extends onto the surface of the metal body of the valve but does not obstruct either the inflow or outflow orifices.There is insufficient soft tissue present for histologic examination.A 2mm defect is noted on the free edge of the valve body on the outflow side.Specimen is submitted for gross examination only.The manufacturing records for the onxa-19, 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 onxa-19, sn (b)(4), was implanted (b)(6) 2006 in the aortic position and was explanted (b)(6) 2016 (10 years 232 days postop) due to a diagnosis of pannus overgrowth.The valve was returned to manufacturer but did not contain enough pannus material to examine histologically.Photographic evidence points strongly to pannus formation at the inlet side of the valve, around the periphery of the flare.The report does not state nature of the obstruction necessitating explantation but photos indicate restricted annulus diameter.The effect on leaflet motion is not indicated in the report, but shape (per photo) of pannus material extracted does not suggest leaflet impediment.The pathology report observed a chipped edge on the outflow side of the valve, the side opposite of the pannus.In situ photographs do no show this chip but do show the presence of metal instruments.The conclusion is that the chip was introduced by the metal instruments during the explanting process and did not contribute to the formation of the pannus.Pannus formation is a rare, but known, adverse event associated with prosthetic heart valves.Sakamoto, et al., for instance, reported 1 case out of 137 recipients (0.73%) of the st.Jude bileaflet valve [sakamoto 2006].They also observed that all of their pannus patients (including their bjork-shiley cohort) were women, an observation reiterated by darwazah [darwazah 2012].Unlike thrombus, pannus is a more chronic process associated with ingrowth of tissue typically requiring surgical intervention [bonnichsen & pellikka 2015].Factors that may contribute to pannus formation are inadequate anticoagulation, infection, wall shear stress, and female gender [darwazah 2012].Although it is rare, prosthesis pannus is recognized as a potential adverse event as listed in the instructions for use (ifu).The root cause for the reported event is pannus formation at periphery of inlet (flared) side of on-x valve in aortic position.However, the cause of pannus formation is indeterminate from evidence available.The observed chipped edge of valve was likely introduced by metal instruments during explanting procedure.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the initial report from the distributor, "could you possibly arrange to send another ¿return kit for explanted valve¿ to me again? this is because we have received a new case with on-x valve stuck and revision surgery has been underwent.The following is the initial information and a lot more is coming later." a (b)(6) female previously underwent aortic valve replacement (avr) and mitral valvuloplasty (mvp) with placement of onxa-19 (sn (b)(4)) on (b)(6) 2006.Intervention was required, "the doctor has found that one side of the leaflets did not partially open when outflowed in (b)(6) 2016 and planned to conduct reoperation in (b)(6) [2016].It is a completely planned reoperation." intervention and explant of valve was performed on (b)(6) 2016.Current patient status reported as "alive and getting better." additional information from the distributor indicated the following: "according to the surgeon¿s comment, the both leaflets were interfered by pannus from infra side causing non-full open.Though, there is no attaching materials or else on the returned valve and no evidence about the pannus interference (see attached photo), surgeon said the cause was pannus.He said he will send us the photo taken while the re-do surgery, in short." the initially referenced photos are attached for review despite a lack of gross evidence of pannus.

• Brand Name: ON-X AORTIC HEART VALVE - 19MM
• 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.; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144
• MDR Report Key: 6152013
• MDR Text Key: 61700375
• Report Number: 1649833-2016-00077
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXA-19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/09/2016
• Date Manufacturer Received: 11/09/2016
• 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: 54 YR