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

Model Number ONXACE-23

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

Patient Problems Aortic Regurgitation (1716); Aortic Dissection (2491)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

A review of the available information was performed.A (b)(6) male patient implanted with onxace-23 (sn (b)(4)) in aortic position with concomitant ascending aorta replacement on (b)(6) 2017 indicated for aortic dissection and required explant/replacement via onxaap-27/29 on (b)(6) 2018 indicated for chronic type i aortic dissection, aortic root aneurysm, severe aortic insufficiency.Operative notes indicate, "he did well initially however, he returned with congestive heart failure type symptoms and was identified as having severe perivalvular leak [pvl] around his valve.He was also noted to have an aortic root dilation with continued dissection throughout his aorta.The patient was transferred to our care due to his congestive heart failure and the complexity of his disease problem." patient history significant for severe congestive heart failure class iv and chronic renal insufficiency.Surgical intervention discovered that the "aortic valve was noted to be dehisced approximately one-half to two-thirds of the way around the valve." the annulus was debrided "but did not appear infected." the root cause for the pvl is annular dehiscence - the valve cuff was separating from the aortic annular tissue.However, the cause of the aortic dissection and subsequent annular dehiscence cannot be discerned based on the available information although the patient does have a history of prior aortic dissection.Whatever the cause, the dissection and pvl resulted in chf which in turn led to renal insufficiency with decreased/inefficient cardiac output.There is no indication that the reported events are attributed to the on-x valve.Pvl is a rare but recognized risk of prosthetic aortic valve replacement, as is the possibility of explantation.In a multi-center study with 142 on-x aortic valves followed for a mean of 4.5 years, only one case of late pvl was observed and it was repaired on re-operation [mcnicholas 2006].Another study of 184 aortic on-x patients reported 5 late pvls, of which 2 were major [palatianos 2007].In a 10-year experience at a single center, 428 on-x implants (264 aortic and 164 mitral) resulted in two cases of paravalvular leak, both considered minor and requiring no intervention [tossios 2007].In a european multi-center study, out of 691 on-x patients followed for a median of 5.5 years and up to 12.6 years, there were 4 observed late incidents of pvl in the aortic position [chambers 2013].Objective performance criterion report a rate of all pvl of 1.2%./patient-year, major pvl of 0.6%/patient-year [iso 5840:2005].The root cause for the reported events is unknown.There is no indication that the reported events are attributed to the on-x valve.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Onxace-23 sn (b)(4) was implanted on (b)(6) 2017 and explanted on (b)(6) 2018.According to operative notes received, "he did well initially; however, he returned with congestive heart failure type symptoms and was identified as having severe perivalvular leak around his valve.He was also noted to have an aortic root dilation with continued dissection throughout his aorta.".

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxace-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.35 year-old male patient implanted with onxace-23 (sn (b)(4) ) in aortic position with concomitant ascending aorta replacement on (b)(6)2017 indicated for aortic dissection and required explant/replacement via onxaap-27/29 on (b)(6)2018 indicated for chronic type i aortic dissection, aortic root aneurysm, severe aortic insufficiency.Operative notes indicate, ¿he did well initially however, he returned with congestive heart failure type symptoms and was identified as having severe perivalvular leak [pvl] around his valve.He was also noted to have an aortic root dilation with continued dissection throughout his aorta.The patient was transferred to our care due to his congestive heart failure and the complexity of his disease problem.¿ patient history significant for severe congestive heart failure class iv and chronic renal insufficiency.Surgical intervention discovered that the ¿aortic valve was noted to be dehisced approximately one-half to two-thirds of the way around the valve.¿ the annulus was debrided ¿but did not appear infected.¿ the root cause for the pvl is annular dehiscence ¿ the valve cuff was separating from the aortic annular tissue.However, the cause of the aortic dissection and subsequent annular dehiscence cannot be discerned based on the available information although the patient does have a history of prior aortic dissection.Whatever the cause, the dissection and pvl resulted in chf which in turn led to renal insufficiency with decreased/inefficient cardiac output.There is no indication that the reported events are attributed to the on-x valve.Pvl is a rare but recognized risk of prosthetic aortic valve replacement, as is the possibility of explantation [instructions for use].In a multicenter study with 142 on-x aortic valves followed for a mean of 4.5 years, only one case of late pvl was observed and it was repaired on re-operation [mcnicholas 2006].Another study of 184 aortic on-x patients reported 5 late pvls, of which 2 were major [palatianos 2007].In a 10-year experience at a single center, 428 on-x implants (264 aortic and 164 mitral) resulted in two cases of paravalvular leak, both considered minor and requiring no intervention [tossios 2007].In a european multicenter study, out of 691 on-x patients followed for a median of 5.5 years and up to 12.6 years, there were 4 observed late incidents of pvl in the aortic position [chambers 2013].Objective performance criterion report a rate of all pvl of 1.2%/patient-year, major pvl of 0.6%/patient-year [iso 5840:2005].The root cause for the reported events is unknown.There is no indication that the reported events are attributed to the on-x valve.This event does not identify additional hazards or modify the probability and severity of existing hazards.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

Onxace-23 sn (b)(4) was implanted on (b)(6)2017 and explanted on (b)(6)2018.According to operative notes received, "he did well initially; however, he returned with congestive heart failure type symptoms and was identified as having severe perivalvular leak around his valve.He was also noted to have an aortic root dilation with continued dissection throughout his aorta.".

• Brand Name: ONX AORTIC CONFORM 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
• MDR Report Key: 7519343
• MDR Text Key: 108434333
• Report Number: 1649833-2018-00027
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 851788001464
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2023
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/16/2018
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR