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

Model Number UNKNOWN

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

Patient Problem Hematoma (1884)

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

Event Description

As reported in the on-x prosthetic heart valve anatomic suture ring post-market study, this patient experienced a major cardiac, hematoma bleeding event.Patient disease etiology is calcific.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 american association for thoracic surgery/society of thoracic surgeons (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.As reported in the post-market study, the patient is a 51 year old white male.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 had a major bleeding event diagnosed as a cardiac hematoma.No other information is available following this observation, including an outcome, as the protocol limits adverse event reporting to 14 days postop.Because the reporting period is limited to 14 days postop, and because this event had to have happened within this period to be so reported, it is likely that the hematoma is a consequence of the surgery.However, we do not have any objective evidence to support this analysis and so we do not have enough information to connect the cause of the event to the on-x valve.In any event, the ifu [instructions for use] recognize bleeding as a potential adverse event following aortic valve replacement.Post-operative bleeding is a recognized potential complication following aortic valve replacement surgery, but we do not have enough information to know what, if any, relationship this bleeding event has to the valve.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.

Event Description

As reported in the on-x prosthetic heart valve anatomic suture ring post-market study, this patient experienced a major cardiac, hematoma bleeding event.Patient disease etiology is calcific.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.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg b; bldg. b; austin TX 78752
• MDR Report Key: 7537753
• MDR Text Key: 109041469
• Report Number: 1649833-2018-00036
• 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: study
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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: 51 YR
• Patient Weight: 78