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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Congestive Heart Failure (1783)

Event Type  Injury  

Manufacturer Narrative

This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and 04/30/2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

As reported in (b)(6), this patient experienced congestive heart failure.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and 04/30/2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.

Event Description

As reported in the on-x prosthetic heart valve anatomic suture ring post-market study, this patient experienced congestive heart failure.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and (b)(6)2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.

Manufacturer Narrative

A review of the available information of the on-x prosthetic heart valve anatomic suture ring post-market study was performed.The purpose of the study is to assess the rate of occurrence of permanent pacemaker implantation within 14 days of surgery with on-x prosthetic heart valve with anatomic sewing ring when used to replace diseased aortic valves in human subjects through the use of a retrospective registry.The protocol for this study is as follows: this study is multicenter and retrospective.All centers will follow a common protocol in which eligible patients will be entered into the registry after the 14th postoperative day.No procedures will be done and only retrospective data covering the preoperative, operative and the first 2 weeks postop will be collected.The valve safety primary endpoint is "occurrence of permanent pacemaker implantation within 14 days of surgery as a valve-related adverse event per the definitions of the aats/sts guidelines." the valve safety secondary endpoint is "occurrence of other valve-related adverse events within 14 days of surgery per the definitions of the aats/sts guidelines." per the information available to us, this study began in 2013.The study was closed out 04/30/2018 and we are now becoming aware of the primary and secondary endpoints reported by all of the centers.For each event, the date of implant, date of event, and valve-identifying information is unknown.The patient of the recently closed on-x prosthetic heart valve anatomic suture ring postmarket registry is a 42 year old white male, nyha ill.By protocol, he is the recipient of an onxan or onxane model on-x valve in the aortic position.He was in sinus rhythm preoperatively with no prior history of cardiac surgery reported.Postoperatively, he was still in sinus rhythm and did not receive a pacemaker, but was diagnosed at a postoperative "unscheduled visit" with congestive heart failure (chf), not valve related.No other information is available after this observation, including an outcome, as the protocol limits adverse event reporting to 14 days postop.Non-valve-related chf is generally associated with either myocardial or conduction failure, but as he was described to still be in sinus rhythm, the more likely cause is myocardial.However, no other information is available to draw any firm physiological association.In any event, there is no indication that the on-x valve contributed to the event.Nonetheless, the instructions for use recognize heart failure as a potential adverse event following aortic valve replacement.Heart failure is a recognized potential complication following aortic valve replacement surgery, but we do not have enough information to know what, if any, relationship this particular diagnosis has to the valve.Based on the limited information, no root cause can be determined.No further action is required at this time.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.

• Brand Name: ON-X PROSTHETIC AORTIC HEART VALVE
• 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: 7550549
• MDR Text Key: 109482777
• Report Number: 1649833-2018-00071
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/30/2018
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 75